Job Description
We are seeking a highly experienced Director to lead regulatory strategy and quality operations across the entire product lifecycle. This senior leadership position combines strategic oversight with hands-on execution and requires regular collaboration with cross-functional teams including engineering, clinical, operations, and external partners.
Key Responsibilities
Quality Assurance
* Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant standards.
* Lead internal and external audits, including regulatory inspections and notified body assessments.
* Oversee risk management activities in accordance with ISO 14971.
* Ensure compliance across design controls, CAPA, supplier quality, and post-market surveillance processes.
* Drive a culture of quality through training, continuous improvement initiatives, and cross-functional collaboration.
Regulatory Affairs
* Develop and execute global regulatory strategies for current and future medical device products.
* Prepare and manage submissions for regulatory approvals (e.g., FDA 510(k), CE Marking under MDR, UKCA, Health Canada).
* Serve as the primary regulatory contact for global authorities and notified bodies.
* Monitor regulatory changes and proactively update internal procedures and roadmaps.
* Support clinical and post-market regulatory activities, including vigilance and complaint handling.
Leadership & Strategy
* Serve as the Management Representative for quality and regulatory matters.
* Contribute to organizational strategy and high-level decision-making.
* Mentor and scale the QA/RA team to support company growth.
* Collaborate closely with R&D, Clinical, Operations, and Commercial teams to ensure alignment between innovation and compliance.
Qualifications and Experience
Essential
* Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory, or related discipline.
* 8-12 years of experience in Quality and Regulatory roles within the medical device industry.
* Proven expertise with ISO 13485, FDA QSR, EU MDR, and global submission processes.
* Demonstrated ability to build and scale compliant systems in fast-paced or high-growth environments.
* Strong leadership, project management, and communication skills.
Preferred
* Experience with software as a medical device (SaMD), digital health, or connected medical devices.
* Familiarity with IEC 62304, ISO 27001, and medical device cybersecurity regulations.
* Background in startups or rapidly scaling companies.
* Industry certifications such as RAC or ASQ are a plus.
Why Join Us?
* Take a senior leadership role in a company committed to technological and clinical innovation.
* Collaborate in a high-impact environment with visibility at the executive level.
* Enjoy flexibility, autonomy, and opportunities for professional growth.
* Competitive compensation and benefits offered.