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Senior RA Specialist

Job description

About the Role

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.