The FotoFinder Group …
FotoFinder GROUP, with its industry-leading brands FotoFinder and DermLite, is a globally active medical device company specializing in AI-powered imaging systems for dermatologists. As a fast-growing, mid-sized with 150 employees, we are driven by our mission to give people around the world access to advanced skin diagnostic technologies to prevent skin cancer.
With over 30 years of innovation and a presence in more than 100 countries, we are recognized worldwide for our excellence and technological leadership in digital skin imaging. We work closely with the leading scientists, dermatologists and physicians – united by our passion for improving skin health through technology.
Headquartered in Bad Birnbach, Germany, and California, USA, we combine global reach with the agility and personal touch of a family-owned business. If you're looking for a place where your ideas matter, your impact is visible, and innovation is part of the everyday – join us in shaping the future of skin imaging.
To drive the growth of our business in Italy we are looking for a
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?
Then please send us your complete application documents by e-mail or post to:
FotoFinder Systems GmbH . Human Resources Department . Industriestr. 12 . 84364 Bad Birnbach
Phone: +49 (0) 8563 977200 . E-Mail: jobs[at]fotofinder.de
For data protection reasons, please send your application documents exclusively by e-mail to jobs@fotofinder.de and not to info@fotofinder.de.
Please also note the data protection information for applicants.