We anticipate the application window for this opening will close on - 7 Mar 2025

 

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

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

As a Senior Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.

This role focuses on automated insulin delivery system products with hardware, software and/or interoperability with other devices or external networks. In this role, you will have primary RA responsibility for multiple Class II and 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 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

Responsibilities may include the following and other duties may be assigned.

• Partner with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new and marketed products. Work with RAS, engineers, and subject matter experts (SME) to resolve potential regulatory issues and questions/deficiencies from regulatory agencies.

• Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.

• Lead the preparation of regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release

• Interact directly with FDA and/or notified body at reviewer level. Lead negotiations and interactions during the review process.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

• Provide regulatory input to product lifecycle planning, in particular, business integration of acquisitions.

• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items.

• Provide feedback and on-going support to product development teams for regulatory issues and questions.

• Ensure personal understanding of all quality policy/system items that are personally applicable.

• Follow all work/quality procedures to ensure quality system compliance and high-quality work

Minimum Requirements: 
Requires a Bachelors degree and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

Preferred Qualifications:

• 10 years of regulatory affairs or similar experience within the healthcare industry (i.e., medical device, biotech, or pharma)

• Prior direct experience within FDA highly preferred

• Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, RTR, C