Job Description
The Senior Regulatory Affairs Specialist is responsible for post-market activities for Administration and Safety System medical devices. They will support department regulatory processes and procedures, supporting strategies for worldwide PMS activities.
Key Responsibilities
* Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in West's 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 with guidance to create 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 along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF).
Requirements
* 5+ years (with bachelor's degree) or 3+ years (with Master's/PhD degree) of medical device regulatory experience.
* Advanced knowledge of global device adverse event/incident reporting requirements.
* Attention to detail with planning, time management and organizational skills.
* Minimum US Class II and EU Class IIa device experience.
* Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971.
* International regulatory competency.
* Good oral communication and technical writing skills.