- Contribute to Approval of New Medical Devices Globally
- Work for a Specialized GxP Consulting Firm
- GxP specialized company and full service quality solution provider across GCP, GLP, GMP & GDP in the Life Science Industry.
- Worldwide clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan.
- Support implementation of MDR 2017/745 and IVDR 2017/746 requirements
- Support projects for Medical Device EU and extra EU registration
- Support Compliance and Quality Management System projects for Medical Device Companies
- Perform audits in Medical Device area
- Degree in technical area
- Strong English language proficiency
- 3 or more years in regulatory affairs and quality assurance areas
- Familiarity with MDR, including ISO 13485, MDD 93/42, 21 CFR part 820, new MDR 2017/745-746
- Opportunity to contribute to approvals of new devices globally
- Participate in CE mark registration in EU
- Work in a truly global organization