The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects
Job Summary
The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects.
This position will begin with an onsite onboarding period of approximately 90 to 120 days, followed by a hybrid work model requiring a minimum of three days per week in the office.
Boston Scientific is committed to solving the challenges that matter most, advancing science for life through innovative medical solutions that improve patient lives and create value for customers.
Matching Summary
The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects.
Salary
Base: $86600 - $164500; Bonus/Equity: Annual bonus target and long-term incentives; Benefits: See www.bscbenefitsconnect.com
Skills & Requirements
Must-have
Regulatory strategy development
Product development lifecycle support
FDA regulations and ISO standards
Interaction with regulatory agencies
Device labeling compliance
Nice-to-have
Continuous improvement fostering
Diverse and high-performing teams
Advancing skills and career
Problem-solver with imagination
Key Requirements
Bachelor's degree in scientific or technical discipline
5 years work experience in Regulatory Affairs or related medical device field
Experience with implantable or active implantable medical devices
Prior experience with PMAs for Class III Medical Devices
Experience supporting product development and sustaining activities