Regulatory Affairs Associate – Maastricht
Merit Medical is a leading manufacturer and marketer of disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit Medical aims to be the world’s most customer-focused healthcare company by understanding customers’ needs and by innovating and delivering a diverse range of products that improve the lives of people throughout the world. For their location in Maastricht, Merit Medical is looking for a motivated Regulatory Affairs Associate.
As a Regulatory Affairs Associate, you will be responsible for supporting the overall activities of the Regulatory Affairs department of the Europe, Middle East and Africa (EMEA) regions.
- Participates on various teams for EU and international submissions within the EMEA region
- Maintains guidance documents and overviews assist teams with their interpretation
- Assists with preparation of regulatory submissions to the FDA, the Notified Body and other regulatory authorities
- Interacts with external partners to accomplish translation and authentication of documentation
- Participates on the Shipment control admin group
- Interacts with various levels of management, external agencies and companies
- Assist with maintaining department systems and provides training when needed
- Remains current on developing regulations and revises systems as directed
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed
- Performs other related duties and tasks as required
- Education equivalent to a Bachelor’s degree in the biological, physical, engineering or material science disciplines
- 2 years of relevant experience
- Basic knowledge of the Medical Devices Directive (93/42/EEC, as amended)
- Basic knowledge of the ISO 13485 Quality Systems Standard
- Self-motivated, self-directing, a strong attention to detail and excellent time management skills
- Strong interpersonal skills and the ability to communicate well, verbally and in writing
- Demonstrated computer skills, preferably related to spreadsheets, Word processing, database, internet research and other applicable software programs
- Working in a high-tech environment related to medical devices
- Good primary and secondary employment conditions
If you have any questions, please contact Robin Bisschoff at +31 6 14 79 56 47.
We look forward to receiving your application. You can apply via the ‘apply’ button or by contacting Robin Bisschoff at +31 6 14 79 56 47.