We are seeking a freelance expert with medical device regulatory experience to deliver a targeted AI-powered solution for active client projects. The solution supports automation and quality improvement in MDR and FDA submission work flows.

You will be responsible for delivering:

Regulatory document validation and completeness checks
Drafting support for CER, PMS, and FDA summaries
Cross-file consistency analysis (risk files, IFUs, CERs, labelling)
Regulatory guidance for non-RA departments

Collaboration with our consultancy team to tailor the solution to each client's regulatory environment
Ensuring alignment with MDR Annex II, FDA PMA, ISO 13485, and QMS processes
Supporting on boarding, training, and documentation as needed

Requirements:

Proven experience in medical device regulatory affairs
Familiarity with MDR, FDA PMA, ISO 13485, and QMS work flows
Ability to interpret and structure regulatory documentation
Technical skills in AI/NLP tools, Python, JSON/Markdown formatting, or similar
Strong communication and delivery skills

Engagement Details:

Start Date: September
Location: Baden-Württemberg, Hybrid
Duration: Project-based

If you're ready to lead the delivery of a focused AI regulatory solution and work directly with medtech clients, we'd love to hear from you.