Regulatory Affairs Specialist I in Schwerte, Germany

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Regulatory Affairs Specialist I

Job 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.

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.

Qualifications:

• Bachelor’s degree in a relevant field and qualifications in regulatory affairs are advantageous.

• Experience in product compliance or regulatory affairs within the relevant industries.

• Proven experience in supporting portfolio expansion initiatives.

Attributes:

• Results-driven and adaptable to fast-paced portfolio growth.

• Strong interpersonal and collaboration skills.

• Proactive problem solver with a strategic mentality.

• Excellent organizational and project management skills

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, protected veteran status, disability or any other legally protected status.