Regulatory Affairs Specialist

Key activities/main objectives

• Manage and ensure compliance with regulatory requirements for the product portfolio.
• Provide regulatory affairs (RA) support for research and development (R&D) projects and product modifications.
• Maintain up-to-date technical documentation for the SCI product lineup.
• Assess product conformity and oversee the conformity assessment process.
• Offer technical and RA expertise for the approval of medical devices.
• Facilitate the global registration process for all products.
• Stay informed about and communicate relevant changes in regulatory legislation and guidelines.
• Report to the RA director or designated authority.

Requirements:

• Master's Degree or equivalent experience in Engineering, Pharmacy, Chemistry, or a related life science field.
• Familiarity with relevant regulations such as MDR, FDA 21 CFR 820, SOR98-282, and TGA, as well as guidelines like FDA, MDGG, and MEDDEV.
• Knowledge of applicable ISO standards.
• Proficiency in project management.
• Strong verbal and written communication abilities.
• You are available for 32-40 hours.
• You live close to Amersfoort.
• You have a valid working permit.

Salary Benefits:

What our client can offer you:

• Salary between 50000-80000 EUR
• Hybrid working
• External and internal trainings

Our client is a medical device company based in Amersfoort. They have been active for over 25 years in the industry. Currently, they are looking for a RA Specialist is accountable for overseeing product groups, conducting RA assessments for product modifications, and ensuring the upkeep of Technical Documentation. Additionally, the RA Specialist provides support to Sales teams for registering products in various countries.