Beschreibung
Regulatory Affairs Specialist (f/m/d)For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Specialist who can support with the development and execution of regulatory strategies.
Key facts:
- Start Date: immediately
- Length: 6 months
- Workload: 100%
- Location: Central Switzerland
Tasks:
- Creation, review and/or approval and maintenance of technical files, significant notifications, Canadian registrations and US 510(k) submissions. Further submission and review interactions with notified body, Health Canada and FDA.
- Development and execution of regulatory strategies for development projects, product change projects, and lifecycle management activities.
- Provide regulatory guidance and strategic planning in projects related to compliance EU, US & CA, under some guidance and supervision.
- Ensuring timely maintenance activities for EU, US & CA including ECOs, STEDs, GSPRCs
Knowledge, skills & Experience
- Min. 4 years experience in medical devices with good experience in regulatory affairs
- Very good knowledge of EU, US, and CA medical device regulation
- Knowledge of design control process requirements and requirements for technical documentation for medical devices.
- Knowledge in requirements and processes for CE, US and CA submissions
- Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485
- Quality and design assurance experience is an advantage
- Hands-on and communicative
- Ability to work in an international matrix organization
- Project management skills
- Fluency in English / German is an advantage
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.