Regulatory Specialist

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.