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?
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International Regulatory Affairs Specialist 30 hours/week [m/f/x] Arbeitgeber: FotoFinder Systems GmbH
FotoFinder ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in den USA und LATAM eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Mitarbeiterentwicklung und Teamarbeit fördern wir eine Kultur des Wachstums und der Zusammenarbeit, die es Ihnen ermöglicht, Ihre Fähigkeiten in der Kundenbetreuung und im technischen Verständnis weiterzuentwickeln. Unsere flexiblen Arbeitsmodelle und die Möglichkeit, an innovativen Projekten im Gesundheitswesen zu arbeiten, machen uns zu einem attraktiven Arbeitsplatz für alle, die eine sinnvolle Karriere anstreben.
