Lead Regulatory Strategy and Quality Operations
We are seeking an experienced director to lead strategic oversight of regulatory affairs and quality operations across the entire product lifecycle. This senior leadership position combines hands-on execution with regular collaboration with cross-functional teams.
* Own, maintain, and continuously improve the Quality Management System (QMS) in compliance with 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 processes.
* Drive a culture of quality through training, continuous improvement initiatives, and cross-functional collaboration.
Regulatory Affairs Expertise
* Develop and execute global regulatory strategies for current and future medical device products.
* Prepare and manage submissions for regulatory approvals.
* 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.
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 teams to ensure alignment between innovation and compliance.
Essential Qualifications
* 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 relevant standards 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 Qualifications
* 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.