You manage regulatory strategies and documentation for FDA and EU submissions, collaborating with various teams to ensure compliance and support clinical evaluations.
Anforderungen
- •Completed university education in a technical field.
- •5+ years of experience in regulatory affairs.
- •Proven success with FDA submissions.
- •Strong knowledge of FDA regulations.
- •Strong analytical skills and creativity.
- •Excellent written and verbal communication skills in English.
- •Independent and solution-oriented approach.
- •Hands-on and structured in a dynamic environment.
Deine Aufgaben
- •Develop and implement regulatory strategy for FDA clearance.
- •Create and maintain regulatory documentation for US and EU submissions.
- •Provide expertise in Regulatory Affairs for development initiatives.
- •Coordinate scheduling and planning of regulatory work.
- •Plan and contribute to clinical evaluation activities.
- •Lead regulatory submissions and interactions with authorities.
- •Collaborate with QA, product, clinical, and engineering teams.
Deine Vorteile
Central office in Munich
Hybrid role with flexibility
Impactful product development
Leading role in innovation
Interdisciplinary and motivated team
Original Beschreibung
## (Senior) Regulatory Affairs Expert (m/f/d)
###### Permanent employee, Full or part-time ·Hybrid,München
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##### Your mission
We want you to join our early-stage university spin-off that has just received its ISO 13485 certification. As an integral part of our team, you will harness your regulatory expertise to …
* … develop and implement the regulatory strategy for FDA clearance (De Novo) and conformity assessment under MDR (class II).
* … create, manage, and maintain regulatory documentation for US and EU submissions.
* … provide Regulatory Affairs expertise to support development and change initiatives.
* … coordinate the scheduling and planning of RA-related work and resource allocation.
* … plan and contribute to clinical evaluation activities, including CEP/CER and post-market surveillance.
* … lead regulatory submissions and interactions with authorities for our SaMD product in an evolving software and machine learning regulatory landscape.
* … collaborate cross-functionally with QA, product, clinical, and engineering teams to ensure regulatory alignment.
##### Your profile
* Completed university education in a technical, scientific, or comparable field of study.
* 5+ years of experience in regulatory affairs for medical devices, with a focus on software products (SaMD).
* Proven success with FDA (510(k)/De Novo) and MDR Class II submissions.
* Strong knowledge of 21 CFR Part 860/807/812, FDA Guidance, MDR, and clinical evaluation processes
* Strong analytical skills combined with creativity and intuition. Excellent written and verbal communication skills in English. German is a plus.
* Independent and solution-oriented approach to work.
* Hands-on, structured, and comfortable working in a dynamic startup environment.