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 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 and groups, such as those responsible for complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, legal, Medical Affairs and field actions. This support consists of, but is not limited to, guidance related to regulations, risk management requirements, assessment of impact on the user, representation of GPM approval and compliance review.

Responsibilities

• Support and collaborate with all groups and teams involved in the PMS and vigilance processes to ensure compliance and maximum reliability, repeatability, effectiveness, and efficiency in their operations including: customer care, global PMS, region/market authorized representative, in-country distributors, and local competent authorities.
• Lead a team that manages and responds to requests for additional information from Competent Authorities, liaising with internal SMEs as appropriate.
• Provide written responses to requests for analysis of adverse events, potential or actual reportable events, and/or potential safety signals identified through data trending or complaint evaluation teams.
• Lead and oversee CCT (Critical Complaint Triage) process.
• Lead and manage a team that supports post market activities in the region, introduction to new markets and expansion of product lines in the region, creating a high performing team with a strong culture of collaboration and trust.
• Support notified body, competent authority, and internal audits of the local regional office and/or PMS and vigilance activities.
• Support the EMEA commercial teams by ensuring the PMS and quality strategies align with and are integrated into overall business objectives.
• Interact with patients/HCPs to obtain additional information and provide other support as part of critical complaint follow up.
• Collaborate cross-functionally to write, compile, and/or provide expert input to compliance documentation for post market, such as device PMS plans, HHEs, CAPAs, legal activities and field actions.
• Acquire and maintain knowledge of assigned products/products and therapies including labeling, indications, populations evaluated, disease state and treatments.
• Partner with other members of RA/QA, legal, Medical Affairs and field staff and provide input in the development of field action plans and safety communications; provide guidance to product issue investigation teams to identify events of interest.
• Maintain knowledge of relevant regulations and guidelines in the medical device industry and the broader life sciences/healthcare/med tech ecosystem, including ISO 14971, FDA, MDCG, IMDRF, and ICH guidelines for classifying and reporting medical device and drug adverse events.
• Contribute to the development and implementation of post-market compliance program initiatives, process improvements, and sound safety principles and practices.
• Provide training and support to international field staff on recognition of customer complaints and appropriate documentation.

Education And Experience Minimum Requirements:

• BA/BS degree from an accredited university or college preferred.
• Experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, and/or Medical/Clinical/Patient Safety in a medical technology, life sciences, or healthcare setting.
• Experience in professional/technical writing in medical technology, regulated industry, life sciences, or healthcare setting.
• Work experience specifically in clinical risk management, compliance or post market safety.
• Fluent in Medical Device regulations- EUMDR, FDA, ISO13485.
• Competent in Microsoft Office programs (e.g., Word, Excel, and PowerPoint).
• Able to assimilate and interpret scientific content and translate information for appropriate audience in a succinct manner.
• Able to quickly learn new technologies.
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills.

Preferred Skills And Competencies:

• Experience in dealing directly with regulatory bodies is highly desired.
• BSN with diabetes experience, Registered Dietician or Diabetic Educator, Clinical licensure in other healthcare discipline desired.
• Experience in SaMD highly desired.
• Experience leading global teams preferred.

Requirements Physical Requirements (if applicable):

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