Product Care Manager (m/f/d) - Research and Development

Thermo Fisher Scientific; Freiburg im Breisgau; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading global diagnostics company in Freiburg is seeking a Product Care Manager (m/f/d) for Research and Development. This role involves the ongoing management and optimization of post-launch products within the autoimmunity division. The ideal candidate will have a Master’s degree in a relevant field, significant experience in medical device development, and strong leadership skills. The position offers a future-oriented work environment, outstanding career prospects, and a strong commitment to innovation.

Leistungen

Outstanding career prospects

Company pension scheme

Innovative company culture

Qualifikationen

• Experience in assay or medical device development required.
• Proven track record in managing product life cycles.
• Fluency in English, German is a plus.

Aufgaben

• Lead CAPA management and ensure timely closure.
• Maintain regulatory compliance for product care activities.
• Collaborate with cross-functional teams on product management.
• Champion continuous improvement initiatives for product quality.
• Prepare for internal and external audits.

Kenntnisse

Leadership

Problem-solving

Project management

Communication

Ausbildung

Master’s degree in biology, Immunology, or related field

Jobbeschreibung

Product Care Manager (m/f/d) - Research and Development

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Location/Division Specific Information

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life

As the Product Care Manager (m/f/d) you will be responsible for the ongoing management and optimization of post-launch products within the Autoimmunity division, ensuring they continuously meet high-quality standards and adapt to evolving market and regulatory requirements. This role involves strategic leadership and close collaboration with cross-functional teams to handle product life cycles effectively, enhance product performance, and maintain compliance with industry standards.

Responsibilities

• CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs.
• Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records.
• Cross-Functional Collaboration: Nurture strong relationships with R&D, Production Planning, Marketing, QA/RA, and other departments to effectively run CAPA and NC processes, ensuring seamless operational flow and adherence to regulatory standards.
• Continuous Improvement: Champion continuous improvement initiatives to enhance product quality and performance, applying root cause analysis to prevent recurrence of issues.
• Audit and Documentation Management: Prepare for and lead defense in internal and external audits; manage and be responsible for the creation and maintenance of all product care documentation to ensure full regulatory compliance.
• Team Leadership: Manage and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion.

Minimum Requirements/Qualifications

• Master’s degree in biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry.
• Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment.
• Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives.
• Exceptional communication skills with fluency in English, both written and spoken, necessary for effective collaboration across diverse teams and collaborators. German is a plus.

What we offer

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.