EMEA Compliance and Vigilance Manager (hybrid)

Insulet Corporation; United Kingdom; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

A leading company in diabetes management is seeking an EMEA Compliance and Vigilance Manager to oversee safety and compliance initiatives. The role involves collaboration across teams within the EMEA region, ensuring adherence to regulatory standards, enhancing post-market surveillance, and developing quality assurance practices. Ideal candidates will possess a BA/BS and relevant experience in medical technology, demonstrating strong communication skills and attention to detail.

Qualifications

• BA/BS degree preferred.
• Experience in regulatory affairs or quality assurance in healthcare.
• Knowledge of EU MDR and ISO 13485 required.

Responsibilities

• Manage compliance and vigilance processes for EMEA.
• Lead responses to requests from Competent Authorities.
• Oversee product launch compliance and post-market activities.

Skills

Quality Assurance

Regulatory Affairs

Post Market Surveillance

Communication

Risk Management

Education

BA/BS degree

Tools

Microsoft Office

Job description

Social network you want to login/join with:

EMEA Compliance and Vigilance Manager (hybrid)

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Client:

Insulet Corporation

Location:

United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

e38db5cc9ad3

Job Views:

3

Posted:

02.07.2025

Expiry Date:

16.08.2025

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Job Description:

The Manager of EMEA Safety and Compliance develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; and serves as a post-market surveillance subject matter expert to the region. This individual will provide support to internal functional teams involved in complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, legal, Medical Affairs, and field actions. Responsibilities include providing guidance on regulations, risk management, impact assessment, and compliance review.

Responsibilities:

Globally, with emphasis on Europe, Middle East, and Africa (EMEA): support and collaborate with all groups involved in PMS and vigilance processes to ensure compliance and effectiveness, including customer care, global PMS, regional representatives, distributors, and authorities.

Lead a team managing responses to requests from Competent Authorities, liaising with SMEs, and providing analysis of adverse events and safety signals.

Oversee critical complaint triage (CCT) process and support post-market activities, product launches, and expansion in the region, fostering a team culture of collaboration and trust.

Support audits and ensure alignment of PMS strategies with business objectives.

Engage with patients and healthcare professionals for additional information and support during complaint follow-up.

Collaborate on compliance documentation, including PMS plans, HHEs, CAPAs, legal activities, and field actions.

Maintain knowledge of products, regulations (ISO 14971, FDA, MDCG, IMDRF, ICH), and industry standards.

Contribute to compliance programs, process improvements, and safety practices.

Provide training on complaint recognition and documentation to field staff.

Education and Experience:

Minimum Requirements:

• BA/BS degree (preferred)
• Experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or Medical/Clinical/Patient Safety in healthcare or medical technology
• Experience in technical writing within regulated industries
• Knowledge of clinical risk management, compliance, or safety
• Fluent in Medical Device regulations (EU MDR, FDA, ISO 13485)
• Proficiency in Microsoft Office
• Ability to interpret scientific content and learn new technologies quickly
• Strong attention to detail and communication skills

Preferred Skills:

• Experience with regulatory bodies
• Healthcare licensure or diabetes-related qualifications
• Experience in SaMD and leading global teams

Physical Requirements: None. Up to 15-20% travel possible.

Insulet Corporation, NASDAQ: PODD, is dedicated to innovating in diabetes management and healthcare. For more info, visit insulet.com and omnipod.com.

We seek motivated, high-performing individuals guided by shared values to join our team and exceed customer expectations.

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