128 Regulatory Oversight jobs in the United Kingdom

Regulatory Affairs Consultant

High Wycombe, South East £59 - £80 Hourly CK Group- Science, Clinical and Technical

Posted 5 days ago

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Job Description

contract
Group are recruiting for a Regulatory Affairs Consultant, to join a company in the Pharmaceutical industry, at their site based in High Wycombe, on a contract basis initially for 6 months.

Salary:

59.18 per hour PAYE or 80.33 per hour Umbrella



Regulatory Affairs Consultant Role:

  • The Regulatory Affairs Consultant EMEA (Self Care) is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
  • Evaluates and coordinates the regulatory deliverables for medicines and food supplements, within their geographical and/or brand area of responsibility.
  • Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
  • Tracks the status of applications under regulatory review and provides updates to the regulatory team.
  • Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes
Your Background :

  • Relevant Bachelor's Degree or higher in Life Sciences, Chemistry, Pharmacy
  • Expertise across a broad spectrum of Regulatory classifications in particular medicine and food supplements in EMEA region
  • Strong knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  • Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  • In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.
Company:

Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.



Location:

This role is based at our clients site in High Wycombe until December 2025, then in Reading from January 2026.This is a hybrid role with 2-3 days expected on site.



Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only).


Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.



INDKA
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Regulatory Affairs Specialist

Hertfordshire, Eastern £40000 - £55000 Annually ARx Recruitment Services

Posted 5 days ago

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Job Description

permanent

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!

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Regulatory Affairs Specialist

WD1 Watford, Eastern ARx Recruitment Services

Posted 2 days ago

Job Viewed

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Job Description

full time

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Consultant

HP10 Wooburn, South East CK Group- Science, Clinical and Technical

Posted 2 days ago

Job Viewed

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Job Description

contract
Group are recruiting for a Regulatory Affairs Consultant, to join a company in the Pharmaceutical industry, at their site based in High Wycombe, on a contract basis initially for 6 months.

Salary:

59.18 per hour PAYE or 80.33 per hour Umbrella



Regulatory Affairs Consultant Role:

  • The Regulatory Affairs Consultant EMEA (Self Care) is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
  • Evaluates and coordinates the regulatory deliverables for medicines and food supplements, within their geographical and/or brand area of responsibility.
  • Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
  • Tracks the status of applications under regulatory review and provides updates to the regulatory team.
  • Works with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes
Your Background :

  • Relevant Bachelor's Degree or higher in Life Sciences, Chemistry, Pharmacy
  • Expertise across a broad spectrum of Regulatory classifications in particular medicine and food supplements in EMEA region
  • Strong knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  • Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  • In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.
Company:

Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.



Location:

This role is based at our clients site in High Wycombe until December 2025, then in Reading from January 2026.This is a hybrid role with 2-3 days expected on site.



Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only).


Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.



INDKA
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Associate

Chippenham, South West Alliance Pharmaceuticals Limited

Posted today

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Job Description

Join a Science-Led Consumer Healthcare Pioneer on an Exciting Growth Journey


Are you ready to be part of something extraordinary? At Alliance, we're a dynamic, science-led consumer healthcare organisation specialising in advanced skincare solutions and vitamins, minerals & supplements (VMS). Backed by innovation and driven by purpose, we're on an exciting journey of transformation and growth — expanding our reach, enhancing our brands, and bringing cutting-edge products to more consumers across the globe.


As we continue to evolve, we’re looking for passionate, curious, and driven individuals to join us. If you’re excited by the opportunity to shape the future of health and wellness in a fast-paced, entrepreneurial environment — this is your moment.


Are you passionate about regulatory affairs in the food supplement or cosmetics sector and excited to shape the future of global innovation? Join our Global Regulatory team at Alliance, where you’ll play a vital role in ensuring compliance while enabling the successful launch of innovative products across international markets.


As a Regulatory Affairs Associate (known as a Regulatory Scientist internally) you’ll act as a subject matter expert in food supplement or cosmetic regulations, providing expert advice and guidance to cross-functional teams. You’ll be central to driving compliance, supporting innovation, and influencing regulatory change in a fast-paced and collaborative environment.


What You’ll Be Doing

  • Supporting the implementation of robust regulatory strategies to ensure compliance and commercial success.
  • Providing regulatory expertise to innovation projects, enabling smooth and timely product launches.
  • Creating, maintaining, and approving regulatory documentation, including submissions to databases.
  • Maintaining the EMEA food supplement or cosmetics portfolio and supporting medical device compliance.
  • Leading departmental Quality Management System (QMS) activities and supporting audits, SOPs, and CAPAs.
  • Representing regulatory affairs in cross-functional meetings, offering clear advisory input.
  • Contributing to industry consultations, forums, and discussions to influence regulatory best practices.
  • Driving continuous professional development for yourself and supporting knowledge growth within the team.


What we’re looking for

We’re seeking someone who brings both technical expertise and a collaborative mindset. You’ll have:

  • A degree (BSc/MSc) in Life Sciences, Nutrition, Food Science, Pharmacy, Chemistry or related discipline.
  • Solid knowledge of UK/EU food supplement or cosmetic regulations (with global exposure desirable).
  • Familiarity with medical device regulations (EU Cosmetics Regulation, MDR, ISO standards).
  • Experience preparing, reviewing, and submitting regulatory dossiers, notifications, and documentation.
  • Working knowledge of QMS processes (SOPs, audits, CAPAs).
  • Strong ability to interpret regulations, advise teams, and support compliance strategies.
  • Proven track record of supporting new product launches through effective regulatory input.
  • Excellent regulatory writing, documentation management, and database submission skills.


What we offer

  • Competitive salary with discretionary bonus
  • 25 days holiday + 1 celebration day + 1 volunteering day + bank holidays, with the option to buy up to 10 extra days
  • Generous pension scheme (up to 10% employer contribution)
  • Life assurance (4x salary)
  • Private medical cover and health cash plan (with options for family cover)
  • Wellbeing support: eye care, flu vaccine, EAP & discounts via Perks at Work
  • Salary sacrifices options with the Cycle scheme and electric vehicle schemes
  • Flexible working and family-friendly policies
  • Global recognition programme & £1,000 referral bonus


If you are looking to make a difference and be part of something exciting, we’d love to hear from you

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

Uxbridge, London Cure Talent

Posted today

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Job Description

Cure Talent are delighted to be partnered with a rapidly growing medical device company with a diverse portfolio spanning IV therapy, diabetes care, surgical, anaesthesia, sexual health and more. As the business continues to expand, we have an exciting opportunity for a Regulatory Affairs Specialist to join their dedicated Quality & Regulatory team.


This is a hybrid role with the expectation of being on site in Uxbridge once a week.


As the new Regulatory Affairs Specialist, you will play a vital role in supporting all Quality and Regulatory activities across the business. You will contribute to the development and maintenance of regulatory documentation, ensure compliance with global standards, and support smooth implementation of evolving regulations, while working closely with internal teams and external stakeholders.


Key Responsibilities

  • Support and maintain the company’s Quality Management System (QMS).
  • Write, review, and maintain technical files and other regulatory documentation (MDD, MDR, IVDR, UKCA, FDA, Procedure Packs).
  • Ensure compliance with UKCA, EU MDR, FDA and relevant ISO standards.
  • Manage document control, updating procedures and product fact sheets.
  • Support product development and UDI processes.
  • Coordinate and support internal and external audits.
  • Monitor regulatory and standards updates, ensuring timely implementation.


Experience and Skills Required

  • Proven Regulatory Affairs experience within the medical device industry, across a range of device classes.
  • Strong knowledge of ISO 13485.
  • Science-based degree or equivalent.
  • Logical, proactive problem-solving skills with strong attention to detail.
  • Excellent report writing, organisational and time management skills.
  • Strong interpersonal skills with the ability to work cross-functionally.
  • Multi-language skills would be an advantage.


If you’re a Regulatory Affairs professional seeking an exciting opportunity to support a broad medical device portfolio and grow with a dynamic business, we’d love to hear from you.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

Uxbridge, London Cure Talent

Posted today

Job Viewed

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Job Description

Cure Talent are delighted to be partnered with a rapidly growing medical device company with a diverse portfolio spanning IV therapy, diabetes care, surgical, anaesthesia, sexual health and more. As the business continues to expand, we have an exciting opportunity for a Regulatory Affairs Specialist to join their dedicated Quality & Regulatory team. This is a hybrid role with the expectation of being on site in Uxbridge once a week. As the new Regulatory Affairs Specialist, you will play a vital role in supporting all Quality and Regulatory activities across the business. You will contribute to the development and maintenance of regulatory documentation, ensure compliance with global standards, and support smooth implementation of evolving regulations, while working closely with internal teams and external stakeholders. Key Responsibilities Support and maintain the company’s Quality Management System (QMS). Write, review, and maintain technical files and other regulatory documentation (MDD, MDR, IVDR, UKCA, FDA, Procedure Packs). Ensure compliance with UKCA, EU MDR, FDA and relevant ISO standards. Manage document control, updating procedures and product fact sheets. Support product development and UDI processes. Coordinate and support internal and external audits. Monitor regulatory and standards updates, ensuring timely implementation. Experience and Skills Required Proven Regulatory Affairs experience within the medical device industry, across a range of device classes. Strong knowledge of ISO 13485. Science-based degree or equivalent. Logical, proactive problem-solving skills with strong attention to detail. Excellent report writing, organisational and time management skills. Strong interpersonal skills with the ability to work cross-functionally. Multi-language skills would be an advantage. If you’re a Regulatory Affairs professional seeking an exciting opportunity to support a broad medical device portfolio and grow with a dynamic business, we’d love to hear from you.
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Regulatory Affairs Associate

Chippenham, South West Alliance Pharmaceuticals Limited

Posted today

Job Viewed

Tap Again To Close

Job Description

Join a Science-Led Consumer Healthcare Pioneer on an Exciting Growth Journey Are you ready to be part of something extraordinary? At Alliance, we're a dynamic, science-led consumer healthcare organisation specialising in advanced skincare solutions and vitamins, minerals & supplements (VMS). Backed by innovation and driven by purpose, we're on an exciting journey of transformation and growth — expanding our reach, enhancing our brands, and bringing cutting-edge products to more consumers across the globe. As we continue to evolve, we’re looking for passionate, curious, and driven individuals to join us. If you’re excited by the opportunity to shape the future of health and wellness in a fast-paced, entrepreneurial environment — this is your moment. Are you passionate about regulatory affairs in the food supplement or cosmetics sector and excited to shape the future of global innovation? Join our Global Regulatory team at Alliance, where you’ll play a vital role in ensuring compliance while enabling the successful launch of innovative products across international markets. As a Regulatory Affairs Associate (known as a Regulatory Scientist internally) you’ll act as a subject matter expert in food supplement or cosmetic regulations, providing expert advice and guidance to cross-functional teams. You’ll be central to driving compliance, supporting innovation, and influencing regulatory change in a fast-paced and collaborative environment. What You’ll Be Doing Supporting the implementation of robust regulatory strategies to ensure compliance and commercial success. Providing regulatory expertise to innovation projects, enabling smooth and timely product launches. Creating, maintaining, and approving regulatory documentation, including submissions to databases. Maintaining the EMEA food supplement or cosmetics portfolio and supporting medical device compliance. Leading departmental Quality Management System (QMS) activities and supporting audits, SOPs, and CAPAs. Representing regulatory affairs in cross-functional meetings, offering clear advisory input. Contributing to industry consultations, forums, and discussions to influence regulatory best practices. Driving continuous professional development for yourself and supporting knowledge growth within the team. What we’re looking for We’re seeking someone who brings both technical expertise and a collaborative mindset. You’ll have: A degree (BSc/MSc) in Life Sciences, Nutrition, Food Science, Pharmacy, Chemistry or related discipline. Solid knowledge of UK/EU food supplement or cosmetic regulations (with global exposure desirable). Familiarity with medical device regulations (EU Cosmetics Regulation, MDR, ISO standards). Experience preparing, reviewing, and submitting regulatory dossiers, notifications, and documentation. Working knowledge of QMS processes (SOPs, audits, CAPAs). Strong ability to interpret regulations, advise teams, and support compliance strategies. Proven track record of supporting new product launches through effective regulatory input. Excellent regulatory writing, documentation management, and database submission skills. What we offer Competitive salary with discretionary bonus 25 days holiday 1 celebration day 1 volunteering day bank holidays, with the option to buy up to 10 extra days Generous pension scheme (up to 10% employer contribution) Life assurance (4x salary) Private medical cover and health cash plan (with options for family cover) Wellbeing support: eye care, flu vaccine, EAP & discounts via Perks at Work Salary sacrifices options with the Cycle scheme and electric vehicle schemes Flexible working and family-friendly policies Global recognition programme & £1,000 referral bonus If you are looking to make a difference and be part of something exciting, we’d love to hear from you
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Regulatory Affairs Assistant

Plymouth, South West Advanced Medical Solutions

Posted today

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Job Description

Regulatory Affairs Assistant - International Registrations. Plymouth. Who are Advanced Medical Solutions? AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law. Job Details Submit and maintain global regulatory approvals on behalf of AMS Group to meet the requirements of the business plan. To support regulatory submissions for new markets and maintaining registrations and licences in existing markets. To support customer audit requests, tender requests and all general requests associated with International Registrations. What will this role involve? Compile and submit regulatory submissions for approval in applicable markets. Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical device framework in the countries registered. Supporting and advising other functions within the business for information and registration requests. Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on product registrations. Support customer market registration activities, within the terms of existing contractual obligations. Participate in and support audits/reviews by regulatory authorities and customers in regards to the International Registrations system including preparation, facilitation and response. Monitor relevant industry-wide International Registration activities. Continuous improvement and development of the international registrations process. Promote and demonstrate Care, Fair and Dare values in the workplace. Promote health and safety policies in the workplace. The role is a key role within the business, interfacing with customers, in - country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis. Implements the International Registrations system for the AMS Group. Due to the nature of the role the individual must be able to deliver to critical deadlines and manage their workload and time effectively, whilst meeting enforced regulatory timelines. What we're looking for? Science based degree (or equivalent), or relevant experience of working in the medical device field, preferably in a regulatory role. Ideally has experience in key market approval requirements within APAC, EMEA and LATAM Regions. Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities. Competent IT skills. The ability to influence and challenge others in a constructive way so as to deliver improvements.
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Regulatory Affairs Manager

Corby, East Midlands PROACT Medical Ltd

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permanent
JOB DESCRIPTION Job Title Regulatory Affairs Manager Salary £40-55k, dependent upon experience Hours Monday-Thursday 9:00-5:00; Friday 9:00-4.00 Office based, Full time Permanent Role, 37.5 hour per week Summary PROACT Medical Ltd is a fast-growing medical device company, specialising in airway management consumables and patient monitoring equipment. We are looking to employ a Regulatory Affairs Manager to oversee the application of the company’s Quality Management System, to ensure compliance with the applicable requirements of the essential requirements of the Medical Devices Directive 93/42/EEC and Medical Device Regulations (EU) 2017/745. Reporting directly to the QA Manager (or in that person’s absence the Managing Director), the successful candidate will be responsible for implementing procedures to ensure the ongoing compliance of the company’s ranges of Class I medical devices, with particular focus on the aspects of Clinical Evaluation Files, Post-Market Surveillance and Risk Management. The position will be based at our head office in Corby, Northants, working as part of the Regulatory Affairs and Quality Assurance Department, with close ties to the product management, warehouse and customer service teams. Main Responsibilities · Managing a hands-on plan of action to audit and improve Technical Files, prioritising the Company’s own manufactured products. This will also involve overseeing and training as necessary other members of staff to assist in these tasks. · Documentation and implementation of improved procedures relating to technical file management, with specific emphasis on: Clinical Evaluation Files Post Market Surveillance Risk Management Ensuring compliance of devices to all applicable regulations. · Drafting, maintenance and review of EC declarations of conformity for PROACT-manufactured devices. · Maintain registration of PROACT Devices on applicable online databases (EUDAMED, DORS, FURLS). · Monitoring the regulatory Landscape, notifying the Company of any relevant changes, and implementing changes as appropriate based on the scope of the Company’s activities. · Evaluating regulatory requirements for new markets and existing international distribution agreements (including FDA). · Work with the Company’s Directors and Managers and our IT team to develop and adjust our own internal software system (PROACT PORTAL) to allow the best and most efficient implementation of MDR and ISO13485:2016 requirements. · Deputising for the QA Manager in their absence, assisting as necessary with the administration of the QMS. Qualifications & Experience The following requirements should be supported by strong qualifications (preferably to degree level), or relevant working experience: Experience of working with Regulatory Affairs within the medical device industry is required, and knowledge of the current medical device regulatory frameworks EU MDR 745/2017, UK MDR SI 618/2002 & US FDA 21 CFR 820 is essential. Strong understanding of the requirements of ISO 13485:2016 Experience drafting Clinical Evaluation Files in compliance with the guidance of MEDDEV 2.7/1 Strong numeracy skills, with a focus on statistical analysis. Good computer skills – advanced understanding of Word, Excel and Outlook is essential. Knowledge of SQL query writing an advantage. Ability to liaise with colleagues, suppliers, customers and regulatory bodies professionally and diplomatically. Proven administrative and organisational skills. Personal Qualities Ability to work on own initiative and in teams effectively. Keen attention to detail. Capacity to take on product knowledge and build relationships with suppliers, customers and colleagues. Willingness to adapt and respond to the varied requirements of a dynamic business. Applications to be submitted with a current CV and covering letter / e-mail to: Evita Misule, PROACT Medical, 9-13 Oakley Hay Lodge, Great Folds Road, Corby, Northants, NN18 9AS
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