Head of Quality and Regulatory
4 weeks ago
Head of Quality and Regulatory Affairs
A 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 global quality standards. This is an exciting opportunity for someone who is passionate about navigating complex regulatory landscapes to bring cutting-edge technologies to market.
You must have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.
Role Overview
- Lead Regulatory Strategy: Develop and execute 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 train team members 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.
Additionally, the Head of Quality will manage the company’s quality systems, including:
- 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.
This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation. Ideal candidates will be passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards.
Please note: We are unable to accept applicants who require sponsorship.
-
Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeJob DescriptionProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Head of Quality and Regulatory Affairs
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeJob DescriptionProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Head of Quality and Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives by innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Job OverviewWe are looking for a proactive and dedicated Head of Quality and...
-
Head of Quality and Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeAbout 52North52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. Our mission is to help people live better lives by innovating, collaborating, and using cutting-edge technology that centre around the people who will engage with it.Job OverviewWe are looking for a proactive and dedicated Head of Quality and...
-
Head of Quality and Regulatory Affairs
3 weeks 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
3 weeks 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 ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Head of Quality and Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeHead of Quality and Regulatory AffairsProTech 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 standards.This...
-
Head of Quality and Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeHead of Quality and Regulatory AffairsProTech 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 standards.This...
-
Head of Quality and Regulatory Affairs
4 weeks 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
4 weeks 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
3 weeks 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
3 weeks 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
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeJob DescriptionAbout 52North52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. We are at an exciting and fast-paced stage of the company's growth and are looking for a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team.As a key member of our...
-
Head of Quality and Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full timeJob DescriptionAbout 52North52North is a med-tech company that aims to reinvent healthcare journeys for all people across the world. We are at an exciting and fast-paced stage of the company's growth and are looking for a proactive and dedicated Head of Quality and Regulatory Affairs to join our collaborative and interdisciplinary team.As a key member of our...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full timeProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter 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...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time{"Lead Regulatory Strategy": "Develop and execute the regulatory strategy for all products across key international markets, ensuring compliance with global quality standards and regulatory requirements. Provide regulatory guidance to the team, ensuring they are up-to-date on global regulatory changes and trained on regulatory requirements. Oversee the...
-
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time{"Lead Regulatory Strategy": "Develop and execute the regulatory strategy for all products across key international markets, ensuring compliance with global quality standards and regulatory requirements. Provide regulatory guidance to the team, ensuring they are up-to-date on global regulatory changes and trained on regulatory requirements. Oversee the...
