Regulatory Affairs Specialist (m/f/d)

Thermo Fisher Scientific Inc.; Neuenbürg; Vor Ort; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

An innovative company is seeking a Regulatory Affairs professional to join their team. This role involves participating in product registration projects, compiling documentation for import licenses, and communicating with regulatory authorities. The ideal candidate will have a university degree in life sciences, experience in regulatory environments, and fluency in both English and German. With a strong emphasis on teamwork and communication, this position offers a chance to contribute to cutting-edge diagnostics that improve patient health. Join a forward-thinking organization that values integrity and innovation while providing outstanding career development opportunities.

Leistungen

Company Pension Scheme

Career Development Prospects

Innovative Company Culture

Fringe Benefits

Qualifikationen

• University degree in life, pharmaceutical, or technical science is required.
• Experience in a regulatory environment and quality management systems is essential.

Aufgaben

• Participate in product registration projects and compile documentation for import licenses.
• Communicate with partners and regulatory authorities in specified countries.

Kenntnisse

Regulatory Environment Experience

Quality Management Systems (ISO 13485)

Fluent in English

Fluent in German

Analytical Skills

Team Working Skills

Communication Skills

Independent Work

Ausbildung

University Degree in Life Sciences

Knowledge in Immunology

Jobbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

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.

A Day in the Life:

• Actively participate in product registration projects on defined global markets
• Compile and submit required documentation to obtain import 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
• Review and approve product documentation
• Contribute to improved routines and processes within the Global Regulatory Affairs team

Keys to Success:

• A University degree in life, pharmaceutical or technical science, knowledge in Immunology is of advantage
• Experience in regulatory environment is a requirement
• Practical experience of quality managed systems (esp. ISO 13485) is a requirement
• 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

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

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.

Apply today! http://jobs.thermofisher.com