Senior Principal Regulatory Affair Specialist - Pre Market MDIS (Medtronic Diabetes Group)

Must Have: Minimum Requirements

• Bachelors degree required
• Requires a University Degree and minimum of 10 years of medical device regulatory experience, or advanced degree with a minimum of 8 years of medical device regulatory experience

Nice to Have

• Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, including IDE and software-containing devices.
• Prior direct involvement with product development teams
• Working knowledge of IEC 60601-series standards
• Software-related regulatory experience required (e.g., IEC62304, FDA Software/Cybersecurity Guidance Documents)
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
• Regulatory Affairs Certification (RAC)
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.
• Ability to compile data and summarize results
• Proficiency in FDA compliance.
• Organized, efficient, process-oriented; high attention to detail
• Effective interpersonal/communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage multiple projects and priorities
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits:  benefits.medtronic.com

This position is eligible for a short-term incentive plan.  Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here.