240 Regulatory Standards jobs in the United Kingdom

The Quality Assurance & Regulatory Affairs (QA/RA) Manager is responsible for maintaining and reviewing the Quality Management System and quality assurance functions

The objective is to drive a behavioral approach across the business and develop the process owners to take ownership of their SOPs.

Drive continuous improvement activities within the QMS and Identify risk to the business to Senior Managers.

Lead all audit processes by the regulators to ensure certification of ISO 9001 and ISO 13485 and compliance to FDA 21 CFR Part 820.

The QA/RA Manager will also be responsible for product registrations, technical file submissions pre region and Regulatory Authority requirement, medical device reporting, documentation, and approvals to support product lifecycle management and market expansion.

The QA/RA Manager will be the Management Representative and Person Responsible for Regulatory Compliance for Mangar International Ltd and will interact with all departments to ensure that our devices meet EU MDR, FDA and other global regulatory requirements, supporting product development from concept through post-market activities.

This role reports to the Head of R&D and has a close working relationship with Mangar Internation Ltd Site Manger.

KEY TASKS & ACCOUNTABILITIES

• Responsible for ensuring that the Company’s Quality Management System (QMS) conforms to the requirements of international standards (ISO 9001 & ISO 13485) and compliant to FDA 21 CFR Part 820.

• Lead on Management Reviews, Feedback, Complaints, CAPA.

• The Company’s Quality Management Representative (QMR).

• Companies Person Responsible for Regulatory Compliance (PRRC).

• Registration of the company’s medical devices with applicable competent authorities.

• Vigilance reporting e.g., medical device adverse incidents to the applicable competent authorities.

• Maintain relationships with the Client's Quality Representatives and any 3rd party regarding quality matters.

• Lead on company quality and monitor the process owners to ensure the company’s processes are delivering their intended outputs.

• Supports the process owners to monitor, report and improve their processes and training of applicable procedures.

• Responsible for reporting on the performance, suitability and effectiveness of the QMS and on opportunities for improvement, to senior management team.

• Conduct, lead and develop audit schedules

• Responsible for ensuring the promotion of customer and patient focus throughout the organisation.

• Quality sign off on product development lifecycle documentation and activities (as appropriate)

• Authorisation/co-ordination of concessions for release of products not covered in standard processes, re-work of any components identified as out of specification (as appropriate based on risk/impact to the company)

• Regulatory Compliance: Ensure ongoing compliance with applicable medical device regulations, standards, and guidance documents across the lifecycle of each product. Maintain knowledge of current and emerging regulations and communicate updates to relevant stakeholders.

• Labelling and UDI Compliance: Review and approve labelling to ensure compliance with regulatory requirements, including UDI requirements. Collaborate with marketing and product teams to ensure accurate product labelling and documentation.

• Support risk management activities and ensure that risk assessments are documented, reviewed.

• Post-Market Surveillance and Vigilance: Assist in post-market surveillance activities, including adverse event reporting, field safety corrective actions, and product recalls, in compliance with MDR, FDA and other global regulatory requirements.

• Cross-Functional Collaboration: Partner with R&D, Quality, Regulatory Affairs, and Marketing teams to ensure requirements are integrated into product development and maintenance processes.

• Training of practices and procedures to cross-functional colleagues within the business as and when required.

Health, Safety and Welfare

It is the postholders responsibility to ensure compliance with all safety procedures and safe working practices, including environmental awareness, wearing of appropriate PPE and uphold all safe working practices and required behaviors.

In addition, all colleagues are required to report any malpractice, breaches or potential risks and contribute to the health, safety and welfare of all colleagues and site visitors.

Skills, Qualifications and Experience

• Education: A degree, preferably in; Life Sciences, Biomedical, Pharmaceutical, Engineering, or a related field.

• commercial experience in Quality Assurance within the medical device industry, with a focus on EU MDR and FDA compliance.

• Knowledge: Strong understanding of EU MDR, as well as international standards & regulations (ISO 13485:2016 & FDA 21 CFR Part 820 etc.).

• Skills:

o Strong managerial skills, with the ability to get the best from team and external team members and efficient delegation when required.

o Strong project management and organisational skills with the ability to handle multiple projects simultaneously and priorities tasks.

o Excellent written and verbal communication skills, with attention to detail in documentation.

o Ability to interpret standards and communicate requirements effectively to cross-functional teams.

• Travel: UK drivers’ license & willingness to travel between company and customer sites as and when required.

The Quality Assurance & Regulatory Affairs (QA/RA) Manager is responsible for maintaining and reviewing the Quality Management System and quality assurance functions

The objective is to drive a behavioral approach across the business and develop the process owners to take ownership of their SOPs.

Drive continuous improvement activities within the QMS and Identify risk to the business to Senior Managers.

Lead all audit processes by the regulators to ensure certification of ISO 9001 and ISO 13485 and compliance to FDA 21 CFR Part 820.

The QA/RA Manager will also be responsible for product registrations, technical file submissions pre region and Regulatory Authority requirement, medical device reporting, documentation, and approvals to support product lifecycle management and market expansion.

The QA/RA Manager will be the Management Representative and Person Responsible for Regulatory Compliance for Mangar International Ltd and will interact with all departments to ensure that our devices meet EU MDR, FDA and other global regulatory requirements, supporting product development from concept through post-market activities.

This role reports to the Head of R&D and has a close working relationship with Mangar Internation Ltd Site Manger.

KEY TASKS & ACCOUNTABILITIES

• Responsible for ensuring that the Company’s Quality Management System (QMS) conforms to the requirements of international standards (ISO 9001 & ISO 13485) and compliant to FDA 21 CFR Part 820.

• Lead on Management Reviews, Feedback, Complaints, CAPA.

• The Company’s Quality Management Representative (QMR).

• Companies Person Responsible for Regulatory Compliance (PRRC).

• Registration of the company’s medical devices with applicable competent authorities.

• Vigilance reporting e.g., medical device adverse incidents to the applicable competent authorities.

• Maintain relationships with the Client's Quality Representatives and any 3rd party regarding quality matters.

• Lead on company quality and monitor the process owners to ensure the company’s processes are delivering their intended outputs.

• Supports the process owners to monitor, report and improve their processes and training of applicable procedures.

• Responsible for reporting on the performance, suitability and effectiveness of the QMS and on opportunities for improvement, to senior management team.

• Conduct, lead and develop audit schedules

• Responsible for ensuring the promotion of customer and patient focus throughout the organisation.

• Quality sign off on product development lifecycle documentation and activities (as appropriate)

• Authorisation/co-ordination of concessions for release of products not covered in standard processes, re-work of any components identified as out of specification (as appropriate based on risk/impact to the company)

• Regulatory Compliance: Ensure ongoing compliance with applicable medical device regulations, standards, and guidance documents across the lifecycle of each product. Maintain knowledge of current and emerging regulations and communicate updates to relevant stakeholders.

• Labelling and UDI Compliance: Review and approve labelling to ensure compliance with regulatory requirements, including UDI requirements. Collaborate with marketing and product teams to ensure accurate product labelling and documentation.

• Support risk management activities and ensure that risk assessments are documented, reviewed.

• Post-Market Surveillance and Vigilance: Assist in post-market surveillance activities, including adverse event reporting, field safety corrective actions, and product recalls, in compliance with MDR, FDA and other global regulatory requirements.

• Cross-Functional Collaboration: Partner with R&D, Quality, Regulatory Affairs, and Marketing teams to ensure requirements are integrated into product development and maintenance processes.

• Training of practices and procedures to cross-functional colleagues within the business as and when required.

Health, Safety and Welfare

It is the postholders responsibility to ensure compliance with all safety procedures and safe working practices, including environmental awareness, wearing of appropriate PPE and uphold all safe working practices and required behaviors.

In addition, all colleagues are required to report any malpractice, breaches or potential risks and contribute to the health, safety and welfare of all colleagues and site visitors.

Skills, Qualifications and Experience

• Education: A degree, preferably in; Life Sciences, Biomedical, Pharmaceutical, Engineering, or a related field.

• commercial experience in Quality Assurance within the medical device industry, with a focus on EU MDR and FDA compliance.

• Knowledge: Strong understanding of EU MDR, as well as international standards & regulations (ISO 13485:2016 & FDA 21 CFR Part 820 etc.).

• Skills:

o Strong managerial skills, with the ability to get the best from team and external team members and efficient delegation when required.

o Strong project management and organisational skills with the ability to handle multiple projects simultaneously and priorities tasks.

o Excellent written and verbal communication skills, with attention to detail in documentation.

o Ability to interpret standards and communicate requirements effectively to cross-functional teams.

• Travel: UK drivers’ license & willingness to travel between company and customer sites as and when required.

NEW VACANCY! (PK8892)

QUALITY ASSURANCE

WEST YORKSHIRE

Total Package - 35K Made Up Of Salary & Bonus + 23 Days Holiday + Bank Holiday (Rising To 28 With Length Of Service) + 4% Company Pension Contribution + Healthcare Package + Dental Plan + Prize Draws + SIPP Pension Scheme + 50 On Your Birthday OR The Day Off

Our client is a leading flexible packing company based in West Yorkshire supplying and converting OPP, laminates, pouches and specialist films with an enviable reputation for customer service, innovation and product quality. Their customers include some of the largest UK food manufacturers!

They are currently looking for a hard-working Quality Assurance professional with the ability to work independently and alongside the Quality Manager. Ensuring consistency in attitude, attention to detail, effective communication and a commitment to continuous improvement that meet their high quality standards.

They now have 3 years consecutive years of AA grade compliance! Including AA grading with non-conformances under Issue 7!

Responsibilities:

• Development, implementation and maintenance of QA procedures in line with the requirements of the aforementioned Standards
• Internal Audits
• Glass and GMP Inspections
• Supporting in customer & 3rd-party audits
• Dealing with any customer information requests
• Supplier/service provider management

The candidate needs to cover most of the below in Experience:

• Experience in the food or packaging industries
• BRCGS Packaging Materials Standard
• ISO 9001:2015 and ISO 14001:2015
• HACCP Level 3
• Food Safety/Hygiene Level 2
• SEDEX and other ESG-related areas, such as EcoVadis & SBTi
• Relevant industry standards, regulations & best practice
• Root Cause Analysis (5-why's)
• Proficient in Microsoft Office
• Internal Auditing

CareerMakers Recruitment is currently looking a Quality Assurer on behalf of our client based in Knowsley, L33 AREA.

Responsibilities:

• Inspecting final products
li>Inspecting the process on how products are being produced.
• Record any issues you may find.
• Labelling and packing may be involved

Skills:

• Previous quality inspecting experience
• Previous experience working in food production

Working hours:

Monday-Friday rotation pattern

Hours: 6am - 3pm, 1pm - 10pm

Finer details:

• On site company gym
• Free parking

Payrate:  £13.59 Per Hour

If you are interested in the role, and have the relevant experience please apply with your CV or give us a call on (phone number removed).

NEW VACANCY! (PK8892)

QUALITY ASSURANCE

WEST YORKSHIRE

Total Package - 35K Made Up Of Salary & Bonus + 23 Days Holiday + Bank Holiday (Rising To 28 With Length Of Service) + 4% Company Pension Contribution + Healthcare Package + Dental Plan + Prize Draws + SIPP Pension Scheme + 50 On Your Birthday OR The Day Off

Our client is a leading flexible packing company based in West Yorkshire supplying and converting OPP, laminates, pouches and specialist films with an enviable reputation for customer service, innovation and product quality. Their customers include some of the largest UK food manufacturers!

They are currently looking for a hard-working Quality Assurance professional with the ability to work independently and alongside the Quality Manager. Ensuring consistency in attitude, attention to detail, effective communication and a commitment to continuous improvement that meet their high quality standards.

They now have 3 years consecutive years of AA grade compliance! Including AA grading with non-conformances under Issue 7!

Responsibilities:

• Development, implementation and maintenance of QA procedures in line with the requirements of the aforementioned Standards
• Internal Audits
• Glass and GMP Inspections
• Supporting in customer & 3rd-party audits
• Dealing with any customer information requests
• Supplier/service provider management

The candidate needs to cover most of the below in Experience:

• Experience in the food or packaging industries
• BRCGS Packaging Materials Standard
• ISO 9001:2015 and ISO 14001:2015
• HACCP Level 3
• Food Safety/Hygiene Level 2
• SEDEX and other ESG-related areas, such as EcoVadis & SBTi
• Relevant industry standards, regulations & best practice
• Root Cause Analysis (5-why's)
• Proficient in Microsoft Office
• Internal Auditing

CareerMakers Recruitment is currently looking a Quality Assurer on behalf of our client based in Knowsley, L33 AREA.

Responsibilities:

• Inspecting final products
li>Inspecting the process on how products are being produced.
• Record any issues you may find.
• Labelling and packing may be involved

Skills:

• Previous quality inspecting experience
• Previous experience working in food production

Working hours:

Monday-Friday rotation pattern

Hours: 6am - 3pm, 1pm - 10pm

Finer details:

• On site company gym
• Free parking

Payrate:  £13.59 Per Hour

If you are interested in the role, and have the relevant experience please apply with your CV or give us a call on (phone number removed).

Undertake proactive monitoring of commissioned services at planned and regular intervals with a designated portfolio of services ensuring that colleagues across ASC are appropriately involved and informed Collate quality assurance information and intelligence from variety of sources including, audits, observations, engagement with service users, carers and service providers through in person visits, telephone and questionnaires to inform safeguarding, contract management, commissioning and procurement activity Access quality of care and support being provided, and measure against contractual obligations, safety and quality standards

Identify improvement areas and make appropriate recommendations to stakeholders for review and improvement.

Ensure service user and carer feedback is captured and used to drive quality improvements for service users Raise concerns on service quality refereed by internal team and through monitoring visits to the Councils governance framework

Work with ASC operational teams, relevant professionals and partner organisations on a regular basis to share market intelligence and agree required actions where service quality concerns are identified

Support any necessary action required to manage suspensions or provider failure that will impact service delivery

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• Understanding our customers needs, business requirements and aims are a key part of this process.
• Have knowledge and understanding of the IATF16949:2016 standard and ensure the company continually meets this standard
• To be successful in this role the candidate will need to understand:
• Development of Project Quality related procedures, Supplier Audit / Visit Reports and Project Quality Reports.
• Day to Day admin of the Project Quality requirements.
• Day to Day admin and compilation of the Quality Procedure Manual.
• Ensuring customer quality requirements are met and adhered to
• Liaison with customers on quality issues
• Compilation of the quality plan
• Preparation and co-ordination of quality projects inc. admin
• Co-ordination and management of Quality Control and Inspection activities
• Resolve quality related problems
• Inspection and compilation of Material / Supplier Lists
• Supplier Audits and visits
• PPAP controls (Production Part Approval Process)
• Continually review and develop the Q.A. System and Manual

As a Quality Assurance Engineer professional in the industrial and manufacturing sector, you will ensure that products meet established standards of quality and reliability. This permanent role is ideal for someone detail-oriented with a passion for maintaining high standards in the Chemical and Manufacturing Sector.

Client Details

This opportunity is with a medium-sized organisation in the industrial and manufacturing sector based in Birkenhead. The company is known for its commitment to quality, innovation, and delivering exceptional products to its clients.

Description

As the Quality Assurance Engineer you will be tasked with the following;

• Support the implementation and maintenance of ISO9001 and other relevant quality standards
• Conduct internal audits and assist in customer/supplier audits
• Investigate quality issues, implement corrective/preventative actions (CAPA), and track non-conformances
• Monitor production processes and liaise with cross-functional teams to ensure compliance with quality specifications
• Develop and maintain quality documentation, SOPs, and inspection plans
• Provide support and training to production staff regarding quality procedures and best practices
• Assist in driving continuous improvement initiatives across the site

Profile

A successful Quality Assurance Engineer professional should have:

• Previous experience in quality assurance within the industrial or manufacturing sector.
• Strong knowledge of quality control processes and standards.
• An understanding of engineering and manufacturing workflows.
• Excellent analytical and problem-solving skills.
• Attention to detail and a proactive approach to resolving issues.
• Ability to work collaboratively across departments.

Job Offer

• Competitive salary range of 35,000-39,000 per annum.
• Opportunities for professional growth and development.
• A supportive working environment in the engineering and manufacturing department.
• Generous holiday allowance and additional company benefits.

This is a fantastic opportunity for a Quality Assurance professional to make a significant impact in the industrial and manufacturing sector. Interested candidates are encouraged to apply promptly.