Have you ever felt frustrated that your hard work is not recognised? Have you reached a point where career evolution is not clear? Need a new challenge? I'm looking for a global regulatory manager. Sit in the midst of all the decisions in the global HQ. Enjoy an international team environment. Join a company that has a clear growth and opportunity plan. Don't delay, apply today
Global Manager Regulatory Affairs - Senior Regulatory Specialist - Have fun at work!
Role: RA manager, new product development projects Industry: Medical Technology Location: Basel
This company is not a, but THE, leader in its field. With high investment in R&D, this company’s state of the art products are at the cutting edge of medical device development. This is an exciting opportunity to work on new product development projects, new product introduction and significant device modifications in cross-functional teams, looking after your own baby, from Inception to market approval.
Experience in regulatory affairs for product development (training will be provided to fill the gaps)
English (German is a benefit)
Note: candidates applying outside of the medical device industry cannot be considered for this role.
You will represent regulatory affairs interests in product development projects
Build technical files in accordance with MDD 93/42 EEC
Support the international teams with product registration in Canada, US and APAC
Managing requests and responses to notified bodies and competent authorities
Lead the development teams through the design control process, advising strategically on each step
Evaluate and mitigate potential product risks as per ISO 14971
Elemed role Specialities Regulatory affairs quality engineering, quality assurance,medical devices jobs Zurich, Basel, Sankt Gallen, Bern, RA jobs, Manager regulatory affairs, regulatory affairs specialist jobs, Direktor regulatory affairs Schweiz, director RA quality management For all positions based in Switzerland, Elemed works with their SECO licensed Swiss partner Accurity GmbH. All candidate applications are handled in accordance with Swiss law
Regulatory Submissions, 510k, PMA, IDE, CE Marking, Regulatory Writing & Filling,Technical File Documentation,Risk & Gap Analysis.Global Product Registrations.Regulatory Strategies World Wide.Notified & Regulatory Body Interaction.Quality Management Systems Audit prep, follow up, or mock Audits.ISO Standards, 13485, 9000, 9001, 14971, 14001,IEC 60601, 21 CFR 820 QA, RA, medical device headhunter, medical device recruitment consultant