288 Certification Specialist jobs in the United Kingdom
Quality Assurance and Regulatory Affairs Consultant
Posted 8 days ago
Job Viewed
Job Description
Are you an experienced clinical professional looking for a new challenge? If so, we have just the opportunity for you!
LFH is a top medical device consultancy company that is seeking a permanent Quality Assurance and Regulatory Affairs Consultant . We are open to full time as well as part time applicants between 3 to 5 days.
What benefits will you get?
Competitive Salary and compensation package: We understand the value of your skills and expertise. We offer:
- A salary of up to £60k pro rata depending on experience
- Company based bonus scheme
- Health benefits including life insurance and critical illness
- Flexible working
Professional growth and development: You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation. Not only this, as the business is rapidly growing year on year, there is no limitations on where you can go in the company with many exciting opportunities ahead !
Stimulating work environment: Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things. Collaborate with cross-functional teams and contribute to the development of crucial clinical documents that impact the advancement of medical technology.
About LFH Regulatory
We work with varying companies, that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel.
Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.
Responsibilities
Attend client meetings both remote and onsite as needed,
Implement full and partial quality management systems, that align with UK, EU, and US requirements/ISO 13485/21 CFR, by creating/writing procedures, controlled forms, and work instructions,
Maintain client quality management systems and provide QMS support to clients,
Conduct gap assessments and audit quality management systems,
Provide support to clients pre, during and post audit, including audit preparation, attending audits and assisting with non-conformities,
Create, maintain and conduct gap assessments on technical file documentation for clients, including but not limited to:
- Risk management,
- Post-market surveillance,
- Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs),
- Clinical Evaluation,
- Biological Evaluation,
- Usability Engineering,
- Instructions for use and labels,
- Applied standards,
Register devices with regulatory authorities,
Review and prepare UK responsible person documentation,
Liaise with notified/approved bodies and competent authorities.
Attend and participate in team meetings both remote and face to face,
Create blog content for LinkedIn/Website and any other form of social media where required,
Create, update, and maintain internal LFH Regulatory business processes and document employee training records,
Attend exhibitions, conferences and network events.
No direct supervisory responsibilities.
Qualifications
- Degree educated or relevant industry experience.
- Scientific, Engineering or Medical background with regulatory experience within the medical devices/IVD sector (ideally 2 or more years’ experience),
- Experience in the compilation and review of Performance Evaluation/ Clinical Evaluation documentation and EU/UK technical documentation for CE/UKCA marking.
- US experience is desirable.
- Assess all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly.
- An understanding of ISO 13485 and/or FDA 21 CFR Part 820.
- Must work well within a team with good interpersonal and communication skills.
- Excellent attention to detail is essential.
- Suitable general IT skills.
To apply you must be based in the UK.
Remote working with occasional travel as and when needed to meet business need.
Technical Specialist Certification Management Systems
Posted 5 days ago
Job Viewed
Job Description
We have a new and exciting role for a Technical Specialist UKAS Accredited Certification Management Systems to support the technical director in managing the complexities around managing the UKAS management system accreditations.
ABOUT YOU
We are currently seeking a Technical Specialist who has knowledge and experience and a broad understanding of the requirements of accreditation standards, ISO/IE.
Regulatory Affairs Manager
Posted 1 day ago
Job Viewed
Job Description
Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.
As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.
Key Responsibilities of Regulatory Affairs Manager :
- Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
- Prepare, submit, and maintain product registration dossiers and regulatory filings.
- To complete the REACH registration of the full product range within the time limits set by ECHA.
- Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
- Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
- Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
- Represent the company with regulatory agencies and industry associations.
- Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts
Qualifications required from Regulatory Affairs Manager :
- Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
- Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
- Working knowledge of international chemical regulations and compliance systems.
- Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.
What We Value:
We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.
This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.
Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.
Regulatory Affairs Specialist
Posted 1 day ago
Job Viewed
Job Description
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!
Regulatory Affairs Assistant
Posted 1 day ago
Job Viewed
Job Description
Regulatory Affairs Assistant - Devon - up to 25,000 + Bonus + Benefits - REF 1935
I am currently recruiting for a Regulatory Affairs Assistant to work for a leading engineering organisation based in Devon. Salary up to 25,000 + Bonus + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Assistant on a permanent basis.
In this role as a Regulatory Affairs Assistant, you will primarily be responsible for the regulatory submissions. This will involve gaining approval for the organisations products within their applicable markets for a range of countries. You will also get involved in post market surveillance, vigilance reporting and field safety correction actions under the supervision or experienced Regulatory professionals.
Essential Requirements:
- Degree in a Science related field (ideally Biology, Biomedical or Chemistry)
Desirable Requirements:
- Previous experience as a Regulatory Affairs Assistant or similar
This is an entry level role, so full training and support will be provided.
This is a fantastic opportunity for a Regulatory Affairs Assistant to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
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!
Regulatory Affairs Assistant
Posted 4 days ago
Job Viewed
Job Description
Regulatory Affairs Assistant - Devon - up to 25,000 + Bonus + Benefits - REF 1935
I am currently recruiting for a Regulatory Affairs Assistant to work for a leading engineering organisation based in Devon. Salary up to 25,000 + Bonus + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Assistant on a permanent basis.
In this role as a Regulatory Affairs Assistant, you will primarily be responsible for the regulatory submissions. This will involve gaining approval for the organisations products within their applicable markets for a range of countries. You will also get involved in post market surveillance, vigilance reporting and field safety correction actions under the supervision or experienced Regulatory professionals.
Essential Requirements:
- Degree in a Science related field (ideally Biology, Biomedical or Chemistry)
Desirable Requirements:
- Previous experience as a Regulatory Affairs Assistant or similar
This is an entry level role, so full training and support will be provided.
This is a fantastic opportunity for a Regulatory Affairs Assistant to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
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Regulatory Affairs Manager
Posted 5 days ago
Job Viewed
Job Description
Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.
As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.
Key Responsibilities of Regulatory Affairs Manager :
- Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
- Prepare, submit, and maintain product registration dossiers and regulatory filings.
- To complete the REACH registration of the full product range within the time limits set by ECHA.
- Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
- Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
- Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
- Represent the company with regulatory agencies and industry associations.
- Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts
Qualifications required from Regulatory Affairs Manager :
- Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
- Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
- Working knowledge of international chemical regulations and compliance systems.
- Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.
What We Value:
We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.
This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.
Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.
Regulatory Affairs Manager
Posted 10 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Regulatory Affairs Manager**
Swindon, UK/Full time
**Work Schedule**
Standard (Mon-Fri)
**Job Description**
**Responsibilities:**
Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies!
+ Perform regulatory surveillance
+ Assess regulatory feasibility of any new request (primary focal point) and address local impact.
+ Establish centre of expertise to be shared within Thermo Fisher network.
+ Externally, participate to working groups within professional bodies.
+ Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP - MS - ISO - GMP certificate) and establishment master documentations (SMF - DMF - device technical file) collaborating with appropriate regulatory agencies.
+ Ensure inspections & key audits readiness and/or participate.
+ Responsible for archiving official documents.
+ Supervise the maintenance of regulatory data bases (Client product registration information, components).
+ Ensure integration of registration information into Production and Quality master documents (process and QC specifications).
+ Participate to the Change Control process by defining regulatory requirements.
+ Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators.
+ Identify areas of regulatory business opportunities (PDS and others).
+ Provide regulatory guidance (strategy definition, requirements assessment).
+ Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review.
+ Supervise Client registration life-cycle activities (renewals, MoH questions).
**Requirements:**
To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have:
+ B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science
+ A minimum of **7** years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities.
+ UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health.
+ Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
+ Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
+ Strong communication and collaboration skills
+ Ability to work with critical timelines.
+ Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Regulatory Affairs Manager
Posted 10 days ago
Job Viewed
Job Description
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email