Job Details

Senior Post Market Compliance Specialist

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

• 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, authoringHealth 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.

Qualifications

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

• 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.

• Working knowledge of current in vitro diagnostics regulations, guidances, and standards specific to post market requirements.
• Advanced verbal and written communication skills including proofreading, scientific writing, presenting positive persuasive arguments, and presentation to various organizational levels.
• Advanced ability to lead, collaborate and influence cross-functional teams to achieve common goals, without direct authority.
• Advanced ability to effectively manage multiple concurrent assignments and proactively independently identify, assess risk for, and develop proactive and creative approaches to barriers to success.
• Working ability to constructively prevent and resolve conflicts.
• Critical thinking capability and decision making.
• Working data-driven, analytical skills.
• Advanced ability to function effectively with ambiguity in a rapidly changing environment.
• Advanced ability in influencing and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
• Working ability to independently identify, assess risk for, and mitigate.
• Advanced ability to be self-motivated, proactive, accountable, hands-on, and flexible.
• Advanced ability to evaluate for sound, systematic problem-solving methodologies.
• Working ability delivering effective presentations and training material.
• Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.

• Strong understanding of the functional and performance principles of in-vitro diagnostic (IVD) products, including reagents, calibrators, controls, software, and instruments.
• Familiarity with IVD technologies such as immunoassays, ELISA, chemiluminescent assays, and multiplex platforms.
• Ability to interpret, analyze, and present data and information for evaluating potential regulatory adverse events (vigilance) and field actions.
• Ability to clearly summarize technical and scientific information in post-market surveillance reports.

• Demonstrated expertise in interpreting, analyzing, summarizing, and presenting complex data and technical information in post-market surveillance documentation.
• Experience in drafting clear, scientifically sound, and defensible regulatory reports for adverse events (vigilance), field actions, and post-market surveillance.
• Advanced experience in submitting regulatory reports and interacting effectively with regulatory agencies on post-market events.

Travel Requirements

• No routine travel requirements.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ...@werfen.com for assistance.