$120K — $160K *
Principal Regulatory Affairs Engineer -Remote/telework 510(k), PMA,(21CFR), FDA law, MDD,
Provide Regulatory Affairs Support for Advanced Innovation New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices and consumer products. Provide direct project support for registration and licensing in the US, Canada and EU and indirect support to the International Market groups for all other licensing. You will work as a Regulatory Affairs Engineer on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
You are responsible for
Working independently on the Regulatory duties, processes and roles outlined below:
Supports and provides regulatory expertise to assigned medical devices and consumer product development projects from initial kickoff to post marketing phase.
Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines.
Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.
Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada).
Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree with 5+ years of related experience in regulatory affairs engineering; or a Master’s degree with 3+ years of related experience in regulatory affairs engineering. RAC preferred. Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position.
3 years of experience in the medical device industry
Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration, labelling and marketing of medical device worldwide
Experience in Design Controls
Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations.
Experience in supporting international registrations and clinical investigations
Base Salary - USD $120,000 to $160,000
10+ to 15 years experience
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Never
Valid through: 12/17/2021