EMEA Compliance and Vigilance Manager (hybrid)

The Manager of EMEA Safety and Compliance develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices to meet customer, regulatory, and client requirements. This individual serves as a post-market surveillance subject matter expert for the region, providing support to 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:

• Support and collaborate with all involved groups in the PMS and vigilance processes across Europe, Middle East, and Africa (EMEA) to ensure compliance, reliability, effectiveness, and efficiency, including customer care, global PMS, authorized representatives, distributors, and authorities.
• Lead a team managing and responding to requests from Competent Authorities, liaising with internal SMEs, and providing analysis and responses to adverse events and safety signals.
• Oversee the Critical Complaint Triage (CCT) process.
• Manage a team supporting post-market activities, new market entries, and product line expansions, fostering a collaborative and high-performing culture.
• Support audits by notified bodies, authorities, and internal teams related to PMS and vigilance activities.
• Align PMS and quality strategies with business objectives to support commercial teams.
• Engage with patients and healthcare professionals for complaint follow-up and additional information.
• Collaborate on compliance documentation such as PMS plans, HHEs, CAPAs, legal activities, and field actions.
• Maintain knowledge of products, labeling, indications, and disease states.
• Partner with RA/QA, legal, Medical Affairs, and field staff on safety communications and investigations.
• Stay informed on relevant regulations and guidelines, including ISO 14971, FDA, MDCG, IMDRF, and ICH.
• Contribute to post-market compliance initiatives, process improvements, and safety principles.
• Provide training to international field staff on complaint recognition and documentation.

Education and Experience:

• BA/BS degree preferred.
• Experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or Medical/Clinical/Patient Safety.
• Experience in technical writing within regulated industries.
• Background in clinical risk management, compliance, or post-market safety.
• Fluency in Medical Device regulations (EUMDR, FDA, ISO13485).
• Proficiency in Microsoft Office.
• Ability to interpret scientific content and adapt communication accordingly.
• Quick learner of new technologies.
• Strong attention to detail and excellent grammatical skills.

Preferred Skills:

• Experience dealing with regulatory bodies.
• Healthcare licensure or specialized certifications (e.g., BSN, Registered Dietician).
• Experience with SaMD.
• Global team leadership experience.

Physical Requirements:

• None, up to 15-20% travel may be required.