Senior Medical Device Regulations Expert
1 week ago
The primary role of the Regulatory Affairs Specialist is to manage post-market activities for medical devices. The specialist will support global regulatory processes and procedures, develop strategies, author documents, and collaborate with international registrations.
Main Responsibilities:- Develop regulatory strategies for overseas medical devices and combination products to ensure compliance with global guidelines, evolving regulations, and industry standards.
- Create regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports for submission to Notified Bodies, EMA, and other global competent authorities.
- Execute global Post Market Surveillance (PMS) activities and assignments for overseas medical devices and combination products within a portfolio.
- Support EU importation requirements for medical devices in accordance with Article 13 of MDR.
- A Bachelor's Degree in a science, math, or engineering field is required; a Master's Degree or PhD in these fields is preferred.
- Minimum of five years of experience in medical device regulation for Bachelors graduates, and three years for Master's and PhD graduates.
- Knowledge and experience of EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485, and US FDA regulations (Title 21 CFR 820).
- Established scientific and quality expertise in medical device regulation.
- Direct engagement with regulatory authorities.
- Regulatory compliance competency in Quality Management Systems.
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