Post-Market Compliance Specialist III- Autoimmunity

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.

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.

Key Accountabilities

• 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.

Networking/Key relationships

• Marketing and Global Systems Support teams
• Commercial teams
• Manufacturing teams
• Regulatory Affairs team
• R&D teams
• Werfen Affiliates
• Technical Support (MTS) team
• Werfen Affiliates

Minimum Knowledge & Experience required for the position:

Education and Knowledge:

• 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.

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.

Travel requirements:No routine travel required.

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.

The annual base salary range for this role is currently $80,000 range to $110,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

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. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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 NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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 NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com