Randstad is one of the world's leading talent companies with the ambition to be the world's most equitable and specialized talent company. Through our "partner for talent" corporate strategy, we find, develop and connect specialized talents with companies - worldwide, locally and always at a high speed. We build high-quality, diverse, and agile teams, while individuals can enjoy a rewarding career path with equitable opportunities.

Randstad Professional is one of Randstad's four specializations and focuses on the placement of specialists and managers in the future-oriented sectors of IT, Engineering, Life Science and Office.

Are you a strategic thinker with a passion for navigating the complex landscape of international medical regulations? We are looking for a dedicated Global Regulatory Affairs Strategy Manager to join the team in Aalen. In this role, you will be a key architect in shaping our market access strategies, ensuring that our innovative healthcare solutions reach patients worldwide while complying with the highest international standards.

This position is initially limited to a duration of 24 months.

We look forward to receiving your application!

• Global Strategy Development: Support the creation of global

regulatory strategies for new business initiatives, ensuring alignment with international frameworks such as FDA, MDR, IVDR, NMPA, and PMDA.

• Strategic Adaptation: Continuously refine regulatory pathways to

support corporate decisions and pivot effectively in response to evolving global legal environments.

• Risk & Opportunity Management: Identify regulatory hurdles and

opportunities early, deriving actionable measures to optimize product lifecycles and accelerate market approvals.

• Cross-Functional Advisory: Provide expert guidance to internal

departments, including R&D, Clinical, Quality, Marketing, and Regulatory Operations, to integrate compliance into the product DNA.

• Authority Liaison: Act as a primary point of contact for regulatory

bodies (e.g., FDA, EMA, BfArM, and Notified Bodies) to clarify requirements and facilitate submissions.

• Trend Monitoring: Stay ahead of the curve by monitoring global

regulatory trends and actively participating in relevant committees to help shape future industry standards.

• M&A & Due Diligence: Support business growth by conducting rigorous

regulatory assessments during due diligence processes for M&A projects.

• Knowledge Leadership: Organize and lead internal training sessions

to foster a proactive regulatory culture and streamline efficient organizational processes.

• Education: University degree (Bachelor or Master) in Regulatory

Affairs, Life Sciences, Medical Technology, Information Technology, Law, or a related field.

• Professional Experience: At least 3+ years of experience in

Regulatory Affairs within Medical Device industry.

• Subject Matter Expertise: In-depth knowledge of international

standards, including ISO 13485, MDSAP, MDR, and FDA requirements. You have a proven track record of interacting with health authorities.

• Portfolio Management: Demonstrated ability to manage multiple

complex projects simultaneously across different geographies and functional silos.

• Soft Skills: Strong negotiation, communication, and stakeholder

engagement skills. You are an analytical problem-solver who can structure complex projects and lead change management initiatives.

• Languages: Fluency in English is required; proficiency in

additional languages is a distinct advantage.

• Attractive salary and long-term job security through affiliation

with the Group

• Up to 30 days vacation per year
• Good chances of being taken on by our business partners
• Targeted training opportunities and free language courses