Post-Market Compliance Specialist III

Werfen • San Diego, CA

5d • $80,000 - $110,000

About The Position

Introduction 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. Overview Job Summary The Post-Market Compliance Specialist III supports product complaint management as well as post-market surveillance and reporting for in-vitro diagnostic (IVD) products. Responsibilities include complaint intake for complex issues, regulatory reportability, technical investigation, laboratory testing, issue risk assessment, documentation and communication with customers and Affiliates for IVD assays and systems. The position is responsible for Post-Market Surveillance, Device Reporting, and Field Action activities. The role Collaborates with other internal teams and global affiliates and contributes to process improvements. The role provides subject matter expertise in technical and customer relationship management to junior members of the team.

Requirements

• Education and Knowledge: Bachelor’s degree in biological science, biochemistry, or similar field required.
• Proficient knowledge of IVD post-market quality system requirements and complaint handling.
• Advanced knowledge of global IVD post-market regulations and standards.
• Advanced knowledge with IVD reagents and diagnostic platforms, such as immunoassays, ELISA, chemiluminescent assays, and bead-based multiplex assays on automated systems.
• Advanced understanding of the functional and performance principles of IVD products, including reagents, calibrators, controls, software, and instrument systems.
• Experience: Minimum of six (6) years of experience in IVD industry in complaint handling, regulatory function, or a closely related technical function, required.
• Minimum of four (4) years of experience in Autoimmunity IVD, required.
• Minimum of four (4) years of hands-on laboratory testing of IVD assays including operation of automated IVD instrumentation, execution of test protocols, analysis of test results, and documentation of activities and results, required.
• Minimum of four (4) years of experience in customer interface responsibilities and complaint handling in an IVD regulated function, required.
• Minimum of four (4) years of post-market compliance and surveillance experience.
• Skills & Capabilities: Proficiency in laboratory techniques, e.g., aseptic techniques, pipetting, dilution, safety, cleaning, measurement, sample handling, blood born pathogen techniques, use of microscopes.
• Advance skills in clear and effective technical and regulatory writing and verbal communication with the ability to concisely summarize complex technical and scientific information.
• Advanced risk assessment skill and analytical decision-making capability.
• Proficient ability to interpret, analyze, and present data in concise and logical fashion.
• Proficient in ability to multitask and manage routine investigations, projects, and tasks with limited supervision in a fast-paced environment.
• Proficient cross-functional communication and collaborative working skills.
• Advanced skills with data analysis, trending, and statistical analysis tools.
• Advanced Microsoft Office suite and SAP systems skills.

Nice To Haves

• Master’s degree preferred.

Responsibilities

• Complaint Management: Intakes, assesses for regulatory reportability, and triages assigned complaints.
• Designs and executes complex experiments and performs complex complaint investigations including investigation approach determination, experimental design, testing, analyses, and resolution.
• Triages investigations to other internal departments or manufacturers as needed and follows up with the escalated parties until complaint resolution.
• Communicates throughout the complaint investigation process from intake to final resolution with customers, affiliates, and internal stakeholders.
• Presents product issues which should potentially be brought to the Quality Review Board or Field Action Board to PMC management.
• Prepares presentations and presents issues to QRB and FARB.
• Laboratory Organization: Maintains laboratory cleanliness and organization.
• Performs routine cleaning and complete required documentation.
• Monitors and maintains inventory levels of laboratory test samples, consumables, reagents, and other materials.
• Ensures laboratory equipment and tools equipment maintenance, calibration, service, and software versions are current.
• Tracking and Trending: Conducts complaint trend analyses and coordinates the preparation of post-market surveillance (PMS) reports.
• Prepares Management Review slides on PMS for department management.
• Field Actions: Authors field action assessments and ensures completion of Health Hazard Evaluations (HHE/HHA) and leads recalls, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and associated regulatory notifications.
• Reportable Events: Completes, files and follow ups on reportable events to regulatory authorities.
• Department Procedures: Assists in drafting, implementing, and maintaining departmental procedures, work instructions, and templates.
• Provides technical guidance and mentoring to junior staff.
• In consultation with department management, develops and executes training for new and developing staff.
• Complies with applicable standard operating procedures, applicable standards and regula-tions, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Demonstrates Werfen values through the quality of work and professional working relationships.
• Other duties as assigned.

Benefits

• This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level