Werfen North America · 18 hours ago
Senior Post Market Compliance Specialist
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $127K/yr
7+ years expWerfen North America is a family-owned, innovative company specializing in diagnostics. The Senior Post Market Compliance Specialist will ensure compliance for on-market devices with global regulations and lead cross-functional teams in post market assessments and reporting.
Health CareManufacturing
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, 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
Qualification
Required
Bachelor's degree in biology, biochemistry, life science, engineering, or equivalent required
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
Preferred
Advanced degree preferred
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Participation in a commission plan
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase