Regulatory Affairs Specialist

vor 4 Monaten

Freiburg, Deutschland Thermo Fisher Scientific Vollzeit

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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.

For the Phadia GmbH site in Freiburg im Breisgau we are looking for a

**Regulatory Affairs Specialist (M/F/d)**

**A day in the Life**:

- Actively participate in product registration projects on defined global markets
- Compile and submit required documentation to obtain registration licenses
- Communicate with internal and external partners and with regulatory authorities in specified countries
- Participate in product development as regulatory expert
- Participate in the vigilance process
- Proactively provide regulatory requirements and communicate clear regulatory strategies for development projects
- Review and approve product documentation
- Contribute to improved routines and processes for the Global Regulatory Affairs team

**Keys to Success**:

- University degree in life, pharmaceutical or technical science, knowledge in Immunology is of advantage
- First working experience in regulatory affairs is a strong plus but no requirement.
- Practical experience of quality managed systems (esp. ISO 13485) is of advantage
- Fluent in English and German, both spoken and written
- Well-structured, analytical approach of tasks
- Excellent team working and communication skills
- Positive attitude and service-oriented mindset
- Skilled to work across departments, in a matrix organization
- Ability of working independently, taking responsibility for the management of processes, projects and timelines

**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.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. 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.

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