Regulatory Affairs Lead Engineer
Req I D
KEY RESPONSIBILITIES & DUTIES:
REGULATORY AFFAIRS LEAD ENGINEER: Create market clearance applications, as needed, for USA, Canada, European Union and Australia.
Support Global Expansion & in-country RA personnel for ROW global product registrations. Create and maintain product summary technical documentation (STED) to support global product registrations.
The RA Lead Engineer is responsible for supporting product development by guiding the Business' product development teams (New Product Development, Sustaining) on required medical device performance and safety standards. Review scientific/engineering materials (protocols/reports), support continuous improvement activities and provide regulatory assessment on proposed changes to marketed devices. Drive safety agency testing planning and execution.
The RA Lead Engineer is responsible for keeping the product portfolio in compliance with worldwide standards and regulations by maintaining awareness of changing global regulatory requirements and communicating the impact to global registration teams to implement the required updates. Facilitate communication and tracking of changes to regulations and standards by creating, maintaining and updating a library of information.
Bachelor's degree in Engineering 7-11 years' experience in regulatory affairs and/or product development in medical devices
Experience with vision devices including software is desirable