Job DescriptionRegulatory Affairs Manager - global Medical Devices company – Basel
NES Global Talent in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise our clients through all recruitment rotes on a daily basis.
Currently we support one of our clients in the Medical Device industry in Basel. In order to strengthen their team there, we are looking for an experienced professional to join them as the Regulatory Affairs Manager. Their current and upcoming global projects in Q1 and Q2 predict growth in the AQ/RA department and they've reached to us for our support.
- Responsible towards meeting the regulatory requirements for the approval of medical devices during the whole product development process
- Ensuring the compliance of the technical documentation of the products according to the regulatory requirements for medical devices
- Monitoring all products for any risk potential
- Support of international registration submissions and in the preparation and execution of audits
- Interdisciplinary cooperation with the brand management through the entire lifecycle in regulatory terms
- Communication of new regulatory approval requirements to R & D as well as brand management and support in the implementation
- Monitoring of any product-related regulatory content, information and release effects
- Performing conformity assessment for the products and taking part in the preparation of the declaration of conformity
- Support and consulting for R & D and brand management in the interpretation of regulatory requirements
- BSc or MSc in Life Science studies, or a corresponding industry experience
- 3-4 years of experience in RA (International products/markets) in Medical Device/Technology field
- Ideally knowledge of MDR or MDD
- Product classification; Definition of applicable standards; Conformity assessment procedures
- MS-Office knowledge, ERP experience is an advantage
- Written and spoken German and English
What is in for you:
- Detailed conversation, introduction and preparation for a successful application with an experienced consultant
- Transparency and support throughout the application process
- Negotiation with clients for better work/contract conditions
- Follow up and update on market relevant opportunities
Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.
For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland.
Keywords: medical device, regulatory affairs, RA, global projects, submissions, regulations, management, MDR, MDD, medical devices