Regulatory Affairs & Quality Assurance Manager
Consultant Francois-Pierre Puech
Date posted 2 de octubre de 2018Paseo de la Castellana 13, 4ª planta 28046, Madrid Robert Walters Spain
Innovative Medical Devices company is actually searching for its Regulatory Affairs & Quality Assurance Manager for its facilities based in Valencia (Spain).
About the Regulatory Affairs & Quality Assurance Manager role
The Regulatory Affairs & Quality Assurance Manager will support the company development by providing knowledge and inputs about product development, tactical and technical guidance regarding GxP, FDA and CE regulations.
Reporting to the CEO of the company and as the Technical Leader, the Regulatory Affairs & Quality Assurance Manager main functions will be to:
- Lead the Regulatory Strategy for the whole portfolio of the company and be the main responsible for keeping updated products technical documentation
- Ensure Quality Compliance for all guidelines for the EU and US Markets
- Lead both internal and external audits
- Foster Quality Excellence culture focusing on Risk Assessment and Design Control and managing deviations, CAPAs and investigations
- Interpret policies, standards and regulations and evaluate potentially critical problems not covered by policies, standards and regulations
- Document and report quality /compliance issues relating to the commercial and clinical processes and products and assume a Post-Market Surveillance responsibility
For this position, we require a mid-senior/senior profile with 5years+ experience in a similar role within the Medical Devices industry or in a leading Inspection and Certification company.
Fluency in English and Spanish is mandatory. Strong analytic and strategic outlook of the Medical Devices industry as well as proven leadership and communication skills.
If you’re recognised to be empathic, team player and team leader, multitask, results oriented and hard-worker, the Regulatory Affairs & Quality Assurance Manager position is made for you. If you also have a hands-on attitude, good strategic mind and impressive under pressure working skills, don’t wait and just apply to this position.