Senior Regulatory Affairs Officer
We are looking for a senior regulatory affairs professional in the medical devices industry.
Our client is a worldwide industry leader in the field of medical devices. As they focus a lot on innovation and have a strong pipeline, this means that you will be strongly involved with setting up the strategy for the portfolio and upcoming products.
You will be responsible for all product registrations and at the same time incorporate the regulatory standards and documentation throughout the whole product lifecycle. This means that there will be a strong interaction with various teams, from development to post-market surveillance.
We are looking for someone with the experience to handle all different technical files, and work from different sources to make sure all regulatory submissions are put in structured processes. You will have to develop certain strategies company wide to ensure the smooth collaboration between different departments and all documentation.
- 3-5 years experience Regulatory Affairs in the medical devices industry
- Experience with product registrations in Europe as well as international (21 CFR, ISO 13485, MDD 93/42 EEC)
- Ability to oversee all technical files and accommodate a smooth collaboration throughout the whole product lifecycle
The company offers a position with a high level of independence and a dynamic and fast paced environment and a highly talented team to work with. You will become an essential part in the company and your work will be visible and valued.
Are you ready to accelerate your career? Send your CV in word format to Sophie van Goethem at S.Goethem@nonstop-devices.ch and I will be in touch with you directly or for more information give me a call at +31 207 0910 70, extension 3250.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
As a specialized recruiter I can offer you unique market knowledge in the field of Quality Assurance and Regulatory Affairs for the medical devices industry in the Netherlands. This is not limited to helping you finding the right role, but also giving you personalized advice on salaries, work conditions and developing a career plan for you.
Key Words: Regulatory Affairs, RAF, RA, REGS, ISO13485, 21 CFR 820, MDD 93/42 EEC, QA, QMS, Post-Market Surveillance, PMS, Medical Devices, Quality Control, GLP, GMP, GDP, Complaint Handling, International, Netherlands.