Senior Regulatory Manager

Description:

As a Senior Regulatory Manager, you'll be pivotal in ensuring regulatory compliance and advancing our groundbreaking technology. You will collaborate with R&D, clinical, and commercial teams to support new product development and global regulatory submissions.

What You’ll Do

• Lead and Manage: Line manage the Regulatory Assistant and coordinate with internal teams.
• Strategic Input: Contribute to regulatory strategy and planning to achieve project goals.
• Study Management: Design and oversee analytical and clinical verification/validation studies.
• Regulatory Submissions: Liaise with regulatory authorities to create and submit device registration materials.
• Post-Market Surveillance: Manage surveillance activities to meet regulatory requirements.
• Compliance Review: Review product promotional materials and external content for compliance.
• Quality Support: Support the ISO13485 quality system and secure/maintain quality accreditations.