Head of Quality and Regulatory Affairs Specialist
1 month ago
Regulatory and Quality Assurance Leadership Opportunity
A leading healthcare technology company is seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to drive the regulatory and quality functions of the organization. This individual will play a critical role in guiding the company's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards and regulatory requirements.
The ideal candidate will have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics. They will be responsible for leading the regulatory strategy for all products across key international markets, providing regulatory guidance to the team, overseeing submissions, and ensuring post-market compliance.
Key Responsibilities:
- Develop and Execute Regulatory Strategy: Lead the development and execution of the regulatory strategy for all products across key international markets.
- Provide Regulatory Guidance: Ensure the team is up-to-date on global regulatory changes and provide training on regulatory requirements.
- Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
- Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
- Manage External Relations: Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.
- Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
- Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
- Audit Leadership: Lead both internal and external audits to ensure ongoing compliance.
Please note: We are unable to accept applicants who require sponsorship.
#J-18808-Ljbffr
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world.Our MissionWe help people live better lives by innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductNeutrocheck was selected as one of a handful of technologies...
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world.Our MissionWe help people live better lives by innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductNeutrocheck was selected as one of a handful of technologies...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance SpecialistNewton Colmore Consulting Ltd is seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join their team in Cambridge. The successful candidate will work closely with the Quality Assurance and Regulatory Affairs Manager to provide quality assurance and regulatory affairs advice on the...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices recruitment team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityA leading healthcare technology company is seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to drive the regulatory and quality functions of the organization. This individual will play a critical role in guiding the company's innovative medical products through the...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityA leading healthcare technology company is seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to drive the regulatory and quality functions of the organization. This individual will play a critical role in guiding the company's innovative medical products through the...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeJob Title: Regulatory Affairs and Quality Assurance SpecialistJob Description:We are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our medical devices team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation...
-
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeJob Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products and the...
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to revolutionise healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as...
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to revolutionise healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as...
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as one of...
-
Head of Quality and Regulatory Affairs
1 month ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52NorthWe are a med-tech company aiming to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives through innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Our Flagship ProductOur flagship product, Neutrocheck, was selected as one of...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityProTech Recruitment Ltd is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityProTech Recruitment Ltd is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityA leading healthcare technology company is seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to drive the regulatory and quality functions of the organization. This individual will play a critical role in guiding the company's innovative medical products through the...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory and Quality Assurance Leadership OpportunityA leading healthcare technology company is seeking a highly skilled and experienced Head of Quality and Regulatory Affairs to drive the regulatory and quality functions of the organization. This individual will play a critical role in guiding the company's innovative medical products through the...
-
Head of Quality and Regulatory
1 month ago
Cambridge, UK, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeHead of Quality and Regulatory AffairsA fast growing healthcare technology company is looking for a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team. This individual will play a critical role in guiding the organisation’s innovative medical products through the regulatory approval process, ensuring compliance with...
-
Regulatory Affairs Specialist
1 week ago
Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to lead our quality and regulatory projects and functions.Key Responsibilities:* Implement, maintain, and improve a comprehensive Quality Management System in accordance with relevant quality standards* Stay updated on global regulatory...
-
Head of Regulatory Affairs Operations
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob Title: Head of Business Operational Excellence M/FDescriptionPOSITION OVERVIEW:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive...
-
Head of Regulatory Affairs Operations
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob Title: Head of Business Operational Excellence M/FDescriptionPOSITION OVERVIEW:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive...
