Regulatory Affairs Specialist III – Diabetes Care (on-site)
Core
Support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities for diabetes care products.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
US regulatory submissions and registration documents for continuous glucose monitors and diabetes care products
Domain
Healthcare / Medical Devices / Diabetes Care
Required skills
Regulatory strategy development, US regulatory submissions (510(k), PMA), change control management, GMP compliance, quality system implementation, technical leadership, problem-solving
Preferred skills
Medical device industry experience, international regulatory submission experience, RAPS certification, scientific data analysis
Technologies
510(k), PMA, GMP
Responsibilities
Execute regulatory requirements for product development and maintenance, develop global regulatory strategies, analyze cumulative product changes for submissions, lead functional groups in data development for submissions, secure product approval, implement and maintain quality system effectiveness, advise on regulatory strategies, sign-off on change control, support resolution of compliance issues
Seniority
Senior, hands-on IC