Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Planet Pharma

Maastricht, Netherlands

Join a forward-thinking organization at the forefront of medical device innovation as a Senior Regulatory Affairs Specialist. In this pivotal role, you will navigate the complexities of regulatory landscapes across the EMEA region, ensuring compliance and facilitating successful market access for cutting-edge products. Your expertise will directly contribute to advancing healthcare solutions and improving lives worldwide.

What You’ll Bring:

• Extensive regulatory knowledge in medical devices, including experience with international standards such as ISO 13485 and directives/regulations like 93/42/EEC and 2017/745
• Proven ability to determine global regulatory pathways, classifications, and submission strategies
• Strong familiarity with the regulatory environments of the EMEA region, including Europe, Middle East, and Africa
• Excellent attention to detail, with robust procedure development and training experience
• Outstanding communication and relationship management skills
• Proficiency in managing multiple projects simultaneously with exceptional time management
• Multilingual capabilities are a plus
• Solid IT skills, including MS 365 and Excel; familiarity with platforms like Monday and Veeva is advantageous

Preferred Education & Experience:

• Bachelor's degree or higher in biological, physical, engineering, or health sciences
• At least four years of related regulatory affairs experience in the medical device sector
• Supervisory experience is a plus