Work SiteSwitzerland / | CHE - All Regions / Basel
Contract TypePermanent [Full-Time]
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Altran deploys its expertise particularly in:
Life Sciences (Pharma, Biotech, and Medical Devices),
Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking
Telecoms
Public sector
Your role
Be aware about new Medical Devices Regulations 'MDR'
Lead dedicated team efforts, e.g. regulatory submissions preparation, root cause analysis, new regulation/standard task force.
Collaborate actively on the development of combination products and on design transfers.
Ensure continued alignment with Regulatory Affairs teams (global and local) requirements and planning.
Ensure continued alignment with Legal teams (global and local) requirements, strategies and planning.
Your profile
PhD, Master Degree in Pharmacist or in Quality Engineering
Min 5 years of experience as QA/RA manager in the medical devices industry (focus on complex medical electrical equipment, including HW, SW and mechanics) with cross functional experience in international environment.
Strong experience in matter of quality assurance/regulatory affairs (class I, IIB).
Excellent knowledge of ISO13485, 21 CFR 820, ISO 14971.
Excellent knowledge of medical device regulations, CE marking, 510 (k), 21 CFR 4 for combination products.
Knowledge of electrical and software development standards (IEC 60601-1, IEC 62304) and of the radio-communication regulations (1999/9/EC, 47 CFR) is a plus.
Languages : English fluent & German is clearly a plus
