Head of Regulatory Affairs – Leading Medical Device Manufacturer
Location: UK – Multi-Site Role
Role Summary:
GxPeople is partnering with a well-established Medical Device Manufacturer & Supplier to find their next senior leader—a Head of Regulatory Affairs. This is a pivotal moment for the business as they transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), making this role a key strategic appointment.
As the Head of Regulatory Affairs, you will oversee Regulatory Compliance across multiple sites, ensuring adherence to ISO 13485, MDR (2017/745), and other global regulatory standards. This role offers a high level of autonomy, leadership, and direct impact on shaping regulatory strategy within a growing organization.
Key Responsibilities:
Regulatory Leadership & Compliance
Lead all Regulatory Affairs activities across multiple sites, ensuring full compliance with ISO 13485, ISO 11135, cGMP, MDD (93/42/EEC), and MDR (2017/745).
Drive the transition from MDD to MDR (Article 120), ensuring compliance at all stages.
Stay up to date with regulatory requirements and international standards, adapting business practices accordingly.
Maintain regulatory licenses to ensure continued business operations and market access.
Technical Documentation & Post-Market Surveillance
Oversee the maintenance and accuracy of technical documentation, including Medical Device Files and EU Declarations of Conformity.
Ensure compliance with Post-Market Surveillance (PMS) and Vigilance Reporting obligations.
Lead the review and approval of product labeling, Instructions for Use (IFUs), and supporting regulatory documentation.
Regulatory Audits & Quality System Management
Act as the primary contact for audits and inspections from Notified Bodies, Competent Authorities, and regulatory agencies.
Lead internal and external audits, ensuring that compliance gaps are identified and addressed in a timely manner.
Work closely with department managers to ensure the Quality Management System (QMS) is effectively maintained and updated.
Stakeholder Engagement & Cross-Functional Collaboration
Act as the company representative for Regulatory Affairs, providing expert guidance to leadership and cross-functional teams.
Provide regulatory training to staff, increasing awareness and understanding of compliance requirements.
Support “virtual manufacturer” suppliers and liaise with EU Competent Authorities and Government Bodies as needed.
Continuous Improvement & Regulatory Strategy
Lead Continuous Improvement initiatives using industry-standard tools such as 5 Whys, 8D, and Root Cause Analysis.
Support CE marking, regional registrations, and manage regulatory submissions for FDA, SFDA, MHRA, and Notified Bodies.
Oversee Regulatory Affairs personnel, ensuring alignment with strategic business goals.
Laboratory & Sterilization Compliance
Ensure compliance with ISO 11135 and oversee sterilization validation and laboratory standards.
Oversee laboratory operations, ensuring testing protocols, validations, and records meet regulatory requirements.
Qualifications & Experience:
Regulatory & Industry Expertise
4+ years of experience in Regulatory Affairs or Quality Management Systems within the Medical Device industry.
Strong knowledge of ISO 13485, MDR (2017/745), and CE certification (including UKCA).
Experience compiling Technical Files and Design Dossiers, ensuring compliance with MDD/MDR.
Familiarity with regulatory requirements for sterilization (ISO 11135).
Ability to assume the role of “Person Responsible for Regulatory Compliance” (PRRC) under Article 15 of MDR.
Leadership & Auditing Expertise
Proven experience leading a Regulatory Affairs team, driving compliance and regulatory excellence.
ISO 13485 Internal Auditor certification is highly desirable.
Strong communication skills with the ability to engage senior stakeholders and regulatory bodies.
Technology & Process Knowledge
Experience reviewing and approving product labeling, ensuring regulatory alignment.
Strong technical understanding of Medical Devices, QMS, and regulatory submissions.
Competency in Microsoft Office (Word, Excel, Outlook) and experience with regulatory databases (e.g., Microsoft Dynamics/Navision).
What’s in It for You?
Senior leadership role with the opportunity to shape regulatory strategy for a growing Medical Device business.
Competitive salary with a strong benefits package.
Work across multiple UK sites, engaging with industry-leading professionals.
High level of autonomy, responsibility, and direct impact on regulatory compliance.
Opportunity to work at the forefront of MDR transition, ensuring compliance with evolving global standards.
If you are an experienced Regulatory Affairs Leader looking for a dynamic, strategic opportunity, please contact us for more details.