Regulatory Affairs Specialist
Core
Regulatory Affairs Specialist supporting innovative medical technologies throughout the product lifecycle for surgical vessel sealing and dissection tools.
Role type
Regulatory Affairs Specialist
Builds
Medical device technologies for surgical procedures
Domain
Healthcare / Medical Devices
Required skills
Regulatory documentation preparation, impact assessment of product changes, audit and inspection support, risk management, regulatory tracking systems, knowledge of global regulations and standards
Preferred skills
FDA and international regulatory requirements, EU MDR/MDD/ISO 13485/ISO 14971 familiarity, Notified Body experience, RAC certification
Technologies
Regulatory submission systems, risk management tools
Responsibilities
Partner with multidisciplinary teams to communicate regulatory requirements, provide input to product development and lifecycle planning, assess regulatory impact of design and process changes, prepare and coordinate documentation for submissions and renewals, support audits and inspections, monitor regulatory tracking systems, stay current on regulations, collaborate to resolve issues and improve processes
Seniority
Mid-level, hands-on IC