Regulatory Affairs Specialist - Innovative Devices
We are looking for an experience regulatory affairs specialist to work with innovative medical devices.
Our client is one of the worldwide leading organizations in its field of expertise. They develop innovative products that are on the forefront of technology. They use a sophisticated technology to offer their customer the best solutions. The company has locations over the whole world and offers great career opportunities.
In this position you are responsible for the regulatory affairs of new products during their whole lifecycle. Product registrations will be done for Europe, but also the US and Canada. You will manage the technical file and all relevant documentation throughout the whole lifecycle. You will also make sure that all the files are maintained up to date. Furthermore you will monitor all designed documents relevant to the products (instructions etc).
- Minimal 3 years experience Regulatory Affairs for high tech medical devices
- Experience with product registrations in EU, US and Canada.
- Experience with audits
- Knowledge of QMS / ISO13485
- Knowledge of IEC 60601 and IEC 62304
- Fluent English
The company offers an attractive package and great career opportunities within the organization.
If you are ready to develop your professional experience to the next level, then send your CV 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, QA, Quality Assurance, ISO 13485, QMS, 21 CFR Part 820, IEC 60601, IEC 62304, IEC 62366, Risk Management, Medical Technology, Medical Devices, Belgium, International, Medical Device Regulation, MDR, 90/385/EEC, 93/42/EEC, 98/79/EC, IVDMD, MDD, AIMD.
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