In this role, you have the opportunity to
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.
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.
You are a part of
As a result of our company renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with the Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
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
KP RECRUITING GROUP
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.
In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.
See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General