Post-Market Compliance Specialist III- Autoimmunity Job at werfen (San Diego)

Job Description

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.

Job Responsibility

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

Requirements

Bachelor’s degree in biological science, biochemistry, or similar field required
Master’s degree preferred
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
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
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

What we offer

medical, dental, and vision insurance
401k plan retirement benefits with an employer match
paid vacation and sick leave
sales roles are eligible for participation in a commission plan
management and select professional roles are eligible for a performance-based bonus

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Post-Market Compliance Specialist III- Autoimmunity

Job Description

Job Responsibility

Requirements

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