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