Regulatory Affairs Manager

Vor 2 Tagen

Zurich, Schweiz Akina Vollzeit

Akina is a leading developer of medical software to empower patients during independent physiotherapy at home. With an AI-driven motion coach and unique entertainment integration, Akina addresses the lack of clinical feedback and motivation that causes 4 out of 5 patients to fail during self-care at home today.

As a regulatory affairs manager at Akina, you will coordinate and lead the execution of the conformity assessment of our novel software-as-a-medical device under MDR in Europe and, in the future, with the FDA in the US. Your work will be in close collaboration with our engineering team, company management and leading external consultants.

Tasks
- Coordinate the conformity assessment of Akina Care, a Class IIa software-as-a-medical-device under MDR
- Lead the drafting of a technical documentation in collaboration with our engineering and design team
- Lead the implementation of a quality management system following ISO 13485
- Manage the communication with notified bodies and external consultancies

**Requirements**:

- At least 3 years of regulatory and/or quality management experience in the European medical device industry
- BSc or higher degree in a relevant field (e.g., medicine, life sciences, computer science, physics)
- Excellent written and verbal communication in English, additional German skills are a strong plus
- In-depth knowledge of the European MDR and relevant standards (e.g., ISO 14971, IEC 62304, IEC 62366)
- Experience in communicating with notified bodies. Additional experience in communicating with the FDA is a plus.
- Experience in working with a quality management system that conformed with ISO 13485. Prior experience in establishing a QMS is a strong plus.
- Strong interpersonal skills, personal drive and full commitment to achieve something exceptional as part of a dedicated team

**Benefits**:

- Chance to directly shape the development and go-to-market of a novel software-as-a-medical-device as part of a young and ambitious team
- Attractive compensation package comprised of cash salary and equity participation
- Beautiful environment with great hiking, MTB trails and lakes nearby, while still located right in Switzerland's largest city, Zurich
- Hybrid work setup with up to 2 days a week working from home
- Team outings, company off-sites, and much more

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