Senior Post Market Compliance Specialist

About the Position

Werfen

Werfen is a growing, family‑owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

The Senior Post Market Compliance Specialist will ensure compliance for on‑market devices with post‑market global regulations for post‑market surveillance, reportable events, vigilance, and field actions. The position will lead cross‑functional teams in post‑market assessments and execution of surveillance, reportability, vigilance, and field actions. The Specialist will represent the company in interactions and communications with regulatory authorities and notified bodies on post‑market reporting.

• Field Actions: Perform assessments to determine whether an issue requires a field action in impacted geographies. Coordinate internal actions, work directly with relevant agencies, manage field action activities, author Health Hazard Evaluation reports, draft and send notifications, and author field action reports to relevant agencies. Compile and review assessments and execution records to ensure compliance with AID procedures and relevant regulations.
  
  Represent the company in post‑market regulatory communications.
• Post‑Market Surveillance Program: Act as subject‑matter expert on global post‑market surveillance requirements. Analyze inputs, create PMS review schedules, adjust as needed, research and analyze regulatory data, lead cross‑functional teams in gathering, analyzing post‑market data, evaluating trends, forming action items, and compiling reports. Ensure transfer of action items into CAPA and Design Control systems and maintain PMS documentation records.
• Reportable Events: Lead and coordinate timely investigations into all potentially reportable incidents, adverse events, and device malfunctions related to Autoimmunity medical devices. Document investigations, decisions and submit mandatory reports to global regulatory agencies. Maintain event records.
• Quality Management System Support: Educate and broaden regulatory knowledge within Werfen teams, benchmark processes, author and maintain departmental procedures and templates, support post‑market function, assist other QRC departments in audit and inspection preparation, and summarize post‑market data for Management Review Meetings.
• Comply with all applicable SOPs, QMS regulations, EHS, Human Resources and other policies.
• Reflect Werfen values in quality of work and working relationships.

Networking/Key Relationships:

• Manufacturing teams
• QA, QE, QPS, and Regulatory teams
• R&D teams including Manufacturing Technical Support
• Marketing and Commercial Teams
• Contract manufacturers and suppliers
• Senior and Executive Management
• Affiliates
• Other Werfen departments and staff
• Regulatory Agencies (Domestic and International)

• Education: Bachelor’s degree in biology, biochemistry, life sciences, engineering, or equivalent required. Advanced degree preferred.
• Experience: Minimum 7 years of progressive quality/regulatory/post‑market compliance experience in in‑vitro diagnostics and/or medical device industry.
  At least 4 years managing post‑market compliance activities including surveillance, field actions, vigilance, and field actions.

Skills & Capabilities:

• Working knowledge of current in‑vitro diagnostics regulations, guidances, and standards specific to post‑market requirements.
• Advanc…