Medical Device Regulatory Specialist
2 days ago
At the core of our mission to improve patient lives, we're a dedicated team connected by a shared purpose.
Job SummaryThis role is pivotal in supporting our regulatory processes and procedures, strategies for worldwide post-market surveillance activities, and maintaining knowledge of current US, EU, and international regulations/guidelines/policies related to medical devices.
The ideal candidate will possess advanced knowledge of global device adverse event/incident reporting requirements, attention to detail with planning, time management, and organizational skills, as well as minimum US Class II and EU Class IIa device experience.
Key Responsibilities:- Execute global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in our portfolio.
- Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities.
- Responsible for complaint monitoring and adverse event reporting globally.
- Author PMS Plans, PMS Reports, including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports, and other reports required by various health authorities.
- Collaborate with cross-functional team members in collecting, reviewing, and analyzing safety and performance data to identify potential adverse safety risks or performance trends.
- Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally.
This role demands strong relationships both internally and externally and the ability to work in a fast-paced environment with changing priorities and constantly evolving regulatory procedures.
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