Regulatory Affairs Specialist (m/f/d)

Fisher Scientific GmbH; Schwerte; On-site; EUR 65,000 - 100,000; Full time

Benefits offered by this job

Pension scheme

Fringe benefits

Job summary

The Thermo Fisher Scientific Inc. team is seeking a Regulatory Affairs Specialist I to ensure products meet global regulatory requirements and to support portfolio expansion across medical devices, biotechnology, and chemical products.

This role emphasizes adaptive compliance evaluation and collaboration with internal teams to drive compliant product introductions. As part of the regulatory affairs function, you will monitor regulatory landscapes, guide risk-informed decisions, and contribute to

Qualifications

• Bachelor's Degree required; no prior experience required.
• Strong technical writing and documentation skills.
• Experience with regulatory submissions and documentation management.
• Excellent verbal and written communication skills in English.

Responsibilities

• Maintain and refine efficient processes for new item creation.
• Prioritize agility in compliance checks to support the timely inclusion of new products.
• Collaborate with suppliers to accelerate the compliance verification process.
• Stay ahead of regulatory changes and industry trends affecting the portfolio.
• Conduct detailed risk assessments for new products to inform decisions.
• Collaborate with cross-functional teams including procurement, logistics, sales, and business development.

Skills

Regulatory submissions

Technical writing

English proficiency

MS Office

Education

Bachelor's Degree

Tools

Regulatory databases

Submission systems

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Regulatory Affairs Specialist (m/f/d)

Job-ID: R-01370504

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 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.

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Discover Impactful Work:

Join our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. This position offers excellent professional development opportunities within our innovative environment focused on serving science.

Position Summary:

The Regulatory Affairs Specialist is crucial to our dynamic distribution operations, specializing in portfolio expansion across diverse product categories, including medical devices, biotechnology, biopharmaceuticals, and chemical products. This role focuses on rapidly and accurately evaluating the compliance of new products and facilitating their seamless integration into our distribution portfolio.

Key Responsibilities:

Agile Compliance Evaluation:

• Maintain and refine efficient processes for new item creation.
• Prioritize agility in compliance checks to support the timely inclusion of new products.

Strategic Portfolio Planning:

• Collaborate with business development and procurement teams to align compliance considerations with strategic goals for portfolio expansion.
• Provide compliance insights to guide decision‑making on new product acquisitions.

Supplier Collaboration and Evaluation:

• Work closely with suppliers to accelerate the compliance verification process.
• Evaluate and establish positive relationships with suppliers based on compliance track record and responsiveness.

Regulatory Landscape monitoring:

• Stay ahead of regulatory changes and industry trends, particularly those impacting new products in the distribution portfolio.
• Proactively communicate regulatory insights to internal teams.

Risk-Informed Portfolio Decisions:

• Conduct detailed risk assessments for new products to inform portfolio expansion decisions.
• Provide risk mitigation strategies and guidance to support informed decision‑making.

Cross-Functional Collaboration:

• Collaborate seamlessly with cross-functional teams, including procurement, logistics, sales, and business development.
• Facilitate effective communication to address compliance-related queries and challenges.

Keys to success:

• Bachelor's Degree required, no prior experience required
• Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
• Additional qualifications in Quality Management or Regulatory Affairs advantageous
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Excellent organizational abilities and attention to detail
• Strong analytical and problem‑solving capabilities
• Effective verbal and written communication skills in English
• Ability to work both independently and collaboratively in a matrix environment
• Experience with regulatory databases and submission systems preferred
• Ability to manage multiple projects and meet deadlines
• Customer‑focused mindset with strong interpersonal skills
• Demonstrates company values of Integrity, Intensity, Innovation, and Involvement

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 , color, religion, \_, orientation, gender identity, national origin, disability or any other legally protected status.