Regulatory Affairs Manager

Regulatory Affairs Manager focuses on drive the eu regulatory pathway under mdr 2017/745 for a new product programme.

What the role involves

• Drive the EU regulatory pathway under MDR 2017/745 for a new product programme.
• Lead regulatory strategy development from early-stage development through to submission and approval, ensuring alignment with global regulatory, clinical and R&D teams.
• Define and own the EU regulatory strategy for a new Class III device under MDR.
• Leading regulatory project management activities, integrating with global RA, Clinical Affairs and R&D teams.
• Maintain regulatory plans aligned to product development milestones.
• Leading Notified Body strategy.

Skills and requirements

• Proven experience within Regulatory Affairs in medical devices.
• Direct experience with Class III devices is essential.
• Demonstrated leadership of regulatory strategy for new product development programmes is essential.
• Strong working knowledge of EU MDR 2017/745 and associated regulatory frameworks.