Title: Head of Regulatory and Quality
Summary:
Join a pioneering leader in medical technology dedicated to advancing patient care and safety. Our client is at the forefront of developing innovative solutions that address critical gaps in diagnostic accuracy and infection prevention. As the Head of Regulatory and Quality, you will play a pivotal role in shaping the regulatory strategy, ensuring compliance and driving quality initiatives that align with our mission to deliver life-changing medical innovations. If you're a result driven professional with a passion for fostering excellence and ensuring the highest standards, we invite you to lead and inspire our dynamic team in transforming healthcare.
The RA/QA Head will be responsible for…
- Guide and mentor the Quality and Regulatory team, setting goals, providing feedback, and fostering professional growth to drive organizational excellence.
- Manage regulatory submissions (510k and EU MDR), provide expertise on domestic and international requirements, and ensure compliance in labeling, marketing, and product documentation.
- Oversee the development and enhancement of the Quality Management System, ensuring audit-readiness, adherence to design controls, and proactive resolution of quality issues.
- Lead post-market activities, including complaint handling, root cause analysis, trend monitoring, vigilance reporting, and responses to regulatory agencies like FDA and ISO.
- Direct supplier quality controls, collaborate with cross-functional teams on new product development, and ensure regulatory and quality standards in materials, processes, and product launches.
The RA/QA Head should have the following qualifications:
- Bachelor's degree in life sciences, engineering, or a related field required; graduate degree strongly preferred.
- Over 10 years in medical technology or life sciences, including 5+ years in quality or regulatory roles, with a preference for start-up experience.
- In-depth knowledge of U.S. and international regulations (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993), including experience with FDA audits and quality system implementation.
- Proven ability to manage all phases of product development, from concept through commercialization, ensuring regulatory compliance and operational excellence.
- Effective in fast-paced, dynamic environments with changing priorities, and open to travel up to 30% of the time.
