Senior Regulatory Affairs Specialist

A leading pharmaceutical and medical device company is seeking an RA Manager to lead regulatory activities, ensuring compliance and overseeing submissions across global markets.

This Role Will Offer You:

• The opportunity to lead a team and drive regulatory strategy in a global environment.
• Exposure to international markets and cross-functional collaboration.
• A competitive salary and bonus structure.
• A chance to work with innovative products in a growing company.

Key Responsibilities

• Develop and execute regulatory strategies for product registration and compliance.
• Manage submissions, renewals, and variations for pharma and medical devices.
• Ensure adherence to MDR EU regulations, GMP, and ISO 13485.
• Lead and mentor the Regulatory Affairs team.
• Collaborate with Quality, Supply Chain, Marketing, and Legal teams.
• Act as a key liaison with regulatory bodies and global affiliates.

Requirements

• 5-7 years of RA experience in pharma/medical devices.
• Strong knowledge of MDR EU regulations & eCTD submissions.
• Proven leadership and team management experience.
• Experience with regulatory agencies and packaging compliance.
• Fluency in French & English.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Manufacturing, and Science

Industries

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research