Regulatory Specialist

Vertragsart:
Vor Ort
Start:
01/2021
Dauer:
6 months
Von:
Real Staffing
Ort:
Switzerland
Eingestellt:
14.01.2021
Land:
flag_no Schweiz
Projekt-ID:
2028131


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.