EMEA Compliance and Vigilance Manager (hybrid)

Insulet Corporation; London; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading medical technology company is seeking an EMEA Compliance and Vigilance Manager to oversee quality assurance methodologies and compliance processes within the EMEA region. This role requires collaboration across teams, managing post-market surveillance, and ensuring adherence to regulations. Ideal candidates will have a background in QA or Regulatory Affairs, a BA/BS degree, and excellent communication skills. Join a performance-driven team committed to innovation and patient safety.

Qualifications

• Experience in QA, Regulatory Affairs, Post Market Surveillance, or Patient Safety in healthcare or medical technology sectors preferred.
• Fluent in Medical Device regulations (EUMDR, FDA, ISO13485) is an advantage.
• Strong attention to detail with excellent grammatical and proofreading skills.

Responsibilities

• Support and collaborate with all involved teams in the PMS and vigilance processes across EMEA.
• Lead a team managing and responding to inquiries from Competent Authorities.
• Develop and implement post-market compliance initiatives and process improvements.

Skills

Attention to detail

Communication skills

Technical writing

Education

BA/BS degree from an accredited university or college

Tools

Microsoft Office suite

Job description

EMEA Compliance and Vigilance Manager (hybrid)

Apply locations: GB - United Kingdom (London - Office) | Full time | Posted 2 Days Ago | Job requisition id REQ-2025-11376

The Manager of EMEA Safety and Compliance develops, establishes, and maintains quality assurance methodologies, systems, and industry best practices for medical devices, meeting customer, regulatory, and client requirements. This individual serves as a post-market surveillance subject matter expert for the region, supporting internal teams such as complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, legal, Medical Affairs, and field actions. Support includes guidance on regulations, risk management, impact assessment, GPM approval, and compliance review.

Responsibilities:

1. Support and collaborate with all involved teams in the PMS and vigilance processes across EMEA to ensure compliance, reliability, effectiveness, and efficiency, including customer care, global PMS, authorized representatives, distributors, and authorities.
2. Lead a team managing and responding to inquiries from Competent Authorities, liaising with SMEs, and providing analysis of adverse events and safety signals.
3. Oversee the Critical Complaint Triage (CCT) process.
4. Manage a team supporting post-market activities, product launches, and expansions, fostering a high-performance, collaborative culture.
5. Support audits of regional offices and PMS/vigilance activities.
6. Align PMS and quality strategies with business objectives to support commercial teams.
7. Engage with patients and healthcare professionals for complaint follow-up and support.
8. Contribute to compliance documentation, including PMS plans, HHEs, CAPAs, and field actions.
9. Maintain knowledge of products, labeling, indications, and disease states.
10. Collaborate on field action plans, safety communications, and event investigations.
11. Stay updated on relevant regulations such as ISO 14971, FDA, MDCG, IMDRF, and ICH guidelines.
12. Develop and implement post-market compliance initiatives, process improvements, and safety practices.
13. Provide training to international field staff on complaint recognition and documentation.

Education and Experience:

• BA/BS degree from an accredited university or college preferred.
• Experience in QA, Regulatory Affairs, Post Market Surveillance, or Patient Safety in healthcare or medical technology sectors preferred.
• Experience in technical writing within regulated industries preferred.
• Background in clinical risk management, compliance, or safety preferred.
• Fluent in Medical Device regulations (EUMDR, FDA, ISO13485) is an advantage.
• Proficiency in Microsoft Office suite.
• Ability to interpret scientific content and communicate effectively.
• Quick learner of new technologies.
• Strong attention to detail with excellent grammatical and proofreading skills.

Preferred Skills and Competencies:

• Experience dealing with regulatory bodies.
• Healthcare licensure or specific experience (e.g., BSN, Registered Dietitian, Diabetic Educator).
• Experience with Software as a Medical Device (SaMD).
• Experience leading global teams.

Physical Requirements: None. Up to 15-20% travel may be required.

Insulet Corporation is committed to innovation in medical devices, exemplified by our Omnipod product platform. We seek motivated, performance-driven individuals guided by shared values to join our expanding team. For more information, visit insulet.com and omnipod.com.

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