Regulatory Affairs Specialist - ET

We anticipate the application window for this opening will close on - 13 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Reg ulatory Affairs Specialist ( RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required .  Primary responsibilities include : developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables . This role primarily focuses on regulatory support for the US and EU markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and /or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. From developing and authoring regulatory submissions to providing critical input on cross-functional development project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company. Position Responsibilities Supports coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions. Supports compiling and producing materials required in submissions, license renewal and annual registrations. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Supports i nteract ions with regulatory authorities during the development and review process to ensure submission approval. RA Representative on cross functional project teams to communicate regulatory r equirements , perform regulatory assessments and prepar e regulatory documentation according to a defined timeline. Perform regulatory assessments on p roduct changes that may be initiated internally or externally. Recommend changes for labeling, manufacturing, marketing, and clinical documentation for regulatory compliance. Review and approve engineering change orders per company procedures, to assure compliance with regulatory requirements. Work with global regions to solve internal regulatory blocks within the supply chain. Creation and/or maintenance of Technical Document, GSPRs, Declaration of Conformity , Risk Classification Assessments. Review and assess impact of NCMRs in a timely manner to support manufacturing goals. Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle maintenance and develop solutions with other me ... (truncated, view full listing at source)