Job Title:
Regulatory Affairs Professional – Post Market
The successful candidate will play a pivotal role in implementing post-market strategies, encompassing PMS activities, vigilance/MDR reporting, and regulatory submissions. Responsibilities include overseeing RA initiatives for design changes and supplier-related modifications, providing support to relevant design teams, and managing trend data for regulatory reporting.
Requirements:
* Bachelor's or Master's degree qualification in Engineering, Science, QA, or related field.
* Minimum of five years' experience at senior regulatory level in the medical device industry.
* Experience in creating regulatory submissions for premarket approval and FDA guidance for sterile implantable products is highly desirable.
* Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and FDA QSRs is essential.