Senior Post Market Compliance Specialist

Overview

Job Summary

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 Sr. Post Market Compliance Specialist will represent company in interactions and communications with regulatory authorities and notified bodies on post market reporting. 

Responsibilities

Key Accountabilities

• Field Actions: Perform field action assessments to determine whether an issue requires a field action in impacted geographies. Coordinate internal actions and work directly with relevant agencies.  Manage field action activities such as organizing consignee list, authoring Health Hazard Evaluation reports, drafting and sending notifications and authoring field action reports to relevant agencies.  Compile and review field action assessments and field execution records to ensure compliance to AID procedures and relevant regulations.  Represent company in interactions and communications with regulatory authorities post market reports. 
• Post Market Surveillance (PMS) Program: Subject Matter Expert on global post-market surveillance requirements. Analyze inputs and create the PMS review schedule. Adjust schedule as new product development and trends necessitate. Research and analyzed post market regulatory data. Lead cross functional teams in gathering, analyzing post market data, evaluating trends, forming action items and compiling PMS reports.  Ensure transfer of action items into CAPA and Design Control systems. Maintain PMS report and supporting documentation records.
• Reportable Events: Lead and coordinate timely investigation into all potentially reportable incidents, adverse events, and device malfunctions related to Autoimmunity manufactured or distributed medical devices and to report those determined to be reportable to the appropriate regulatory agencies. Documenting each investigation fully including the triggering complaint, investigation actions taken, investigation findings, and the reportability decision. Create and submit mandatory reports to global regulatory agencies. Maintain reportable event and supporting documentation records.
• Quality Management System Support: Assist in the education and broadening the regulatory knowledge within the Werfen teams. Benchmark Autoimmunity Regulatory processes against other Werfen manufacturers and provide continuous improvement for efficiency. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Post Market processes. Owner of CAPAs related to Post Market processes.  Support Post Market function and assist other QRC departments in audit and inspection preparation. Summarizing post market data for presentation at Management Review Meetings.
• Comply with all applicable standard operating procedures (SOPs), applicable QMS regulations and standards, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
• Reflect Werfen Values in the quality of work and in 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)

Qualifications

Minimum Knowledge & Experience required for the position:

Education:

• Bachelor’s degree in biology, biochemistry, life science, engineering, or equivalent required. Advanced degree preferred

Experience:

• A minimum of 7 years of progressive quality/regulatory/post market compliance experience in in-vitro diagnostics and/or medical device industry.
• At least 4 years of experience managing post market compliance activities including post market surveillance, field actions, vigilance, and field actions.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

 

Skills & Capabilities:

• Working knowledge of current in vitro diagnostics regulations, guidances, and standard