Principal Regulatory Affairs Specialist
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. In this role, you will be responsible for providing regulatory support to the product development process, including submissions and compliance.
Key Responsibilities:
* Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
* Assist with departmental policy and procedure implementation.
* Assist with Regulatory Affairs training to cross functional groups.
* Generate and implement regulatory strategies for new and modified medical devices.
* Act as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
* Review and update of EU Regulatory Documentation including Technical Documentation and Post Market Surveillance deliverables such as SSCPs.
* Prepare FDA regulatory files such as pre-market approval (PMA's), supplements and amendments, 30-day notices, annual reports and 510ks.
* Interface with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
Education & Experience: Level 8 Bachelors Degree in STEM (regulatory affairs or relevant discipline)
Minimum of 7 years experience in Regulatory Affairs or a related discipline (e.g. Quality, R&D, Post Market) within the medical device industry
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
Prior experience with a variety of regulatory submissions for US and EU MDR