Radix Engineering is recruiting on behalf of a leading global medical device company.

We are seeking a highly talented and strategic Regulatory Affairs Program Lead to drive global regulatory programs and lead complex regulatory pathways from product development through worldwide market approvals. This is an excellent opportunity for an experienced Regulatory Affairs professional looking to make a significant impact within a dynamic and innovative organization.

Key Responsibilities

• Develop, execute, and manage comprehensive regulatory strategies and pathways for innovative and modified medical devices.
• Lead the preparation and submission of complex FDA and international regulatory filings to support timely global market approvals.
• Ensure product development activities and clinical studies align with applicable regulatory requirements and business objectives.
• Serve as the primary regulatory interface with global regulatory authorities, including FDA, DEKRA, NMPA, and PMDA, as well as regional affiliates worldwide.
• Collaborate closely with cross-functional teams, including R&D, Clinical, Quality, and other key stakeholders, to support successful product development and commercialization.

Requirements

• Bachelor's degree or higher in a relevant scientific or engineering discipline.
• 6–8 years of Regulatory Affairs experience within the medical device industry (pharmaceutical experience is not applicable).
• Proven expertise in managing complex regulatory pathways and international regulatory submissions.
• Strong leadership skills, strategic thinking, and excellent communication abilities.
• Willingness and ability to travel internationally up to 10% of the time.