International Regulatory Affairs Specialist 30 hours/week [m/f/x]

International Regulatory Affairs Specialist

30 hours/week |m/f/x

To strengthen our team, we are looking for an International Regulatory Affairs Specialist (m/f/d) to join us starting January 2027. In this role, you will independently drive our international regulatory approvals and successfully bring our products to new markets.

Location: Bad Birnbach (Remote or Hybrid )
Start Date: January 2027
Employment Type: 30 hours/week

Your responsibilities

• Independently plan, prepare, and submit international regulatory dossiers for the entire FotoFinder and DermLite product portfolio
• Conduct and coordinate registrations in international target markets (e.g., the U.S., Canada, Australia, the U.K., Asia, and other countries)
• Support FDA 510(k) submissions, including communication with the FDA
• Managing international registrations throughout the entire product lifecycle (new approvals, changes, renewals, and product maintenance)
• Developing regulatory strategies for new products and market entries in close collaboration with Sales, Product Management, and Development
• Supporting the MDSAP program and assisting with audits
• Collaborating with international sales partners and local registration agents
• Monitoring regulatory changes and assessing their impact on existing approvals
• Working closely with Quality Management, Development, and Product Management

Your profile

• Degree in a natural science, technical, or medical field, or a comparable qualification
• Several years of professional experience in international regulatory affairs for medical devices
• Practical experience with international product registrations and regulatory submissions, particularly in the target markets of the U.S., Canada, Brazil, and Australia (MDSAP)
• Ideally, experience with the approval of medical software (SaMD) or networked medical devices
• An independent, structured, and solution-oriented approach to work
• Enthusiasm for independently implementing international regulatory projects
• Proficient written and spoken skills in German and English

What we offer

• A versatile position with autonomy at an internationally successful company.
• A modern workplace and flexible work schedules tailored to your individual circumstances (work-from-home).
• An attractive compensation package
• Fitness benefits including a personal trainer and BusinessBike leasing (also for personal use)
• A wide range of training and development opportunities.
• An open, supportive team and a genuine work-life balance.

Interested?