Regulatory Specialist
Firmenname für PREMIUM-Mitglieder sichtbar
Projektbeschreibung
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.
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.
Kontaktdaten
Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.
Ähnliche Projekte
Projekt Insights
Kategorien und Skills
Finanzen, Versicherung, Recht:
Sie suchen Freelancer?
Schreiben Sie Ihr Projekt aus und erhalten Sie noch heute passende Angebote.
Jetzt Projekt erstellen »