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!
Here's what we offer
1. Attractive salary and long-term job security through affiliation with the Group
2. Up to 30 days vacation per year
3. Good chances of being taken on by our business partners
4. Targeted training opportunities and free language courses
Your tasks
5. 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 .
6. Strategic Adaptation: Continuously refine regulatory pathways to support corporate decisions and pivot effectively in response to evolving global legal environments.
7. Risk & Opportunity Management: Identify regulatory hurdles and opportunities early, deriving actionable measures to optimize product lifecycles and accelerate market approvals.
8. 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.
9. Authority Liaison: Act as a primary point of contact for regulatory bodies (eg, FDA, EMA, BfArM, and Notified Bodies ) to clarify requirements and facilitate submissions.
10. Trend Monitoring: Stay ahead of the curve by monitoring global regulatory trends and actively participating in relevant committees to help shape future industry standards.
11. M&A & Due Diligence: Support business growth by conducting rigorous regulatory assessments during due diligence processes for M&A projects.
12. Knowledge Leadership: Organize and lead internal training sessions to foster a proactive regulatory culture and streamline efficient organizational processes.
Your profile
13. Education: University degree (Bachelor or Master) in Regulatory Affairs, Life Sciences, Medical Technology, Information Technology, Law, or a related field.
14. Professional Experience: At least 3+ years of experience in Regulatory Affairs within Medical Device industry.
15. 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.
16. Portfolio Management: Demonstrated ability to manage multiple complex projects simultaneously across different geographies and functional silos.
17. 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.
18. Languages: Fluency in English is required; Proficiency in additional languages is a distinct advantage.