Principal Regulatory Affairs Specialist
Core
Principal Regulatory Affairs Specialist supporting global regulatory submissions, compliance, and strategy for medical device product development and new business partnerships.
Role type
Principal Regulatory Affairs Specialist (Medical Devices)
Builds
Global regulatory applications and compliance strategies for medical devices
Domain
Medical Devices / Healthcare
Required skills
US/EU/China regulatory strategy, 510(k) submissions, EU MDR, international registration, FDA/EU regulations, design control, quality system regulations, clinical trial regulations, capital equipment/device expertise, single-use disposable device expertise
Preferred skills
OEM/contract manufacturer experience, multi-project management, technical writing, independent work
Technologies
Microsoft Office
Responsibilities
Provide technical guidance and regulatory training to teams; Act as company representative with device reviewers; Develop regulatory strategies for new/modified devices and OEM partnerships; Liaise with new business partners for product registration; Coordinate regulatory feedback in product development; Prepare and submit global regulatory applications; Review labeling/advertising for compliance; Sign off on product/manufacturing changes; Support Quality initiatives; Develop departmental policies; Support strategic initiatives
Seniority
Principal, strategy & mentorship