Global Regulatory Affairs Strategy Manager (m/f/d)

Our Offer:

• Attractive compensation according to collective agreement in pay group 9.
• Permanent employment within the framework of temporary employment in full-time with 35 hours per week.
• You will work in an exciting environment at the Aalen location.

Your future workplace: We are looking for you as a Global Regulatory Affairs Strategy Manager (m/f/d) in Aalen at the earliest possible date.

Your tasks:

• Support the development of global regulatory strategies for new or changing business initiatives, taking into account international requirements (e.g. FDA, MDR, IVDR, NMPA, PMDA). Collaborate with external partners and stakeholders to ensure that new business initiatives meet all regulatory requirements in different markets. Adapt regulatory strategies to support strategic decisions and respond to changes in the regulatory environment.
• Identify regulatory opportunities and risks and derive measures to optimize market approval and product lifecycles.
• Evaluate and interpret regulatory requirements in different markets to support the development of innovative solutions and create competitive advantage.
• Provide advice to internal teams (e.g. R&D, Clinical, Quality, Marketing, SSC, Regulatory Operations) to support regulatory strategies.
• Communication with regulatory authorities (e.g. FDA, EMA, BfArM, notified bodies) to gain clarity on regulatory requirements.
• Monitoring of regulatory trends and changes, deriving adaptation strategies and helping to shape regulatory developments in relevant committees.
• Supporting due diligence processes and regulatory assessments as part of M&A projects.
• Organizes trainings for internal teams to anticipate regulatory requirements and design efficient processes.

Your profile:

• Education: Bachelor or Master, in Regulatory Affairs, Life Sciences, Medical Industry, Information Technology, law or related fields
• Experience: 3+ years of experience in Regulatory Affairs within the Life Sciences or Medical industry, with a strong understanding of local, regional, and international regulatory requirements.
• Knowledge: In-depth knowledge of international regulatory requirements (e.g. FDA, MDR, ISO 13485, MDSAP, etc.) and experience in developing proactive regulatory strategies and interacting with authorities.
• Portfolio management: Experience in managing several parallel projects across geographies and functional areas.
• Skills:
• Communication, negotiation, collaboration and stakeholder engagement.
• Strategic thinking with analytical skills and strong problem-solving skills Ability to structure complex projects and drive change management.
• Personal drive and resilience to achieve successful outcomes.
• Languages: Proficiency in English; additional languages are an advantage.

Your partner: The Orizon Gruppe, with over 50 locations, is one of the leading personnel service providers in Germany and part of the international group BREXA Holdings Inc. We offer personnel solutions ranging from classic temporary employment to specialized recruiting and outsourcing services. Our subsidiaries OTTO Work Force Deutschland GmbH and jobs in time medical GmbH complement the portfolio with a focus on EU recruiting and medical specialists, respectively.

Application and inquiries: We look forward to receiving your applications (stating availability and salary expectations) via email to bewerbung.ostwuerttemberg@orizon.de or via our application module on this page. For questions, Ms. Rukwid is available at the telephone number +49 7321 93450. The salary stated here may not include all components (e.g. industry supplements, Christmas bonuses, shift bonuses, etc.). The binding salary is to be clarified in a personal interview. Further information can be found at orizon.de We take the protection of your personal data seriously: www.orizon.de/de/datenschutzvereinbarungen