We are seeking a visionary Director to lead our regulatory strategy and quality operations across the entire product lifecycle.
About the Role
* Develop and implement a Quality Management System (QMS) that meets international standards, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations.
* Oversee risk management activities in accordance with ISO 14971 and ensure compliance across design controls, CAPA, supplier quality, and post-market surveillance processes.
Regulatory Strategy
* Design and execute global regulatory strategies for current and future medical device products, ensuring timely submissions for regulatory approvals.
* Serve as the primary regulatory contact for global authorities and notified bodies, monitoring regulatory changes and proactively updating internal procedures.
Leadership & Collaboration
* Contribute to organizational strategy and high-level decision-making, driving business growth through quality and regulatory excellence.
* Mentor and scale the QA/RA team, fostering collaboration between R&D, Clinical, Operations, and Commercial teams to align innovation with compliance.