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
Principal Regulatory Affairs Specialist – Global Regulatory Strategy and Advocacy position sits in the regulatory organization of Medtronic Diabetes and is charged with cross-functional collaboration to help build and advocate for innovative global regulatory strategies for next generation diabetes devices. These strategies will require a global mindset and critical thinking skills related to cutting edge regulatory topics such as digital health technologies like AI and SaMD to cybersecurity. In this role, you will work in a heavily matrixed environment consisting of specialists from every aspect of the device lifecycle.
Your work will be focused on supporting all activities to advance new product technologies from a regulatory perspective, which can include optimizing workflows and processes. This intersectionality provides an excellent entry point for those with experience in other areas of the medical device space who are looking to evolve their careers, including those with backgrounds in device advocacy, systems engineering, software design, cybersecurity, and/or quality assurance. This position is best suited for professionals desiring to develop their career in device innovation and digital health advocacy at the world’s leading medical device company.
Responsibilities may include the following and other duties may be assigned.
- Develop and refine fit-for-purpose regulatory strategies to support innovations in the Diabetes business with stakeholders across the business—US, EU, international regulatory teams as well as from various partner functions such as quality assurance and R&D.
- Maintain proficiency of worldwide regulatory intelligence, including competitor filings, as part of developing innovative regulatory strategies.
- Establish advocacy channels and maintain good relationships with regulatory agency personnel, allies in industry, and advocacy organizations to promote our objectives in the global regulatory landscape.
- Manage projects assigned to support business improvement initiatives including process improvement and maintenance.
- Socialize strategies, advocacy efforts, and new learnings with our partners to resolve potential regulatory issues and questions that may arise from regulatory agencies to achieve desired results. All significant issues will be reviewed with the manager.
- Provide strategic input for preparation of submission packages (e.g. PMAs, 510k, Technical file dossiers, international submissions, etc.).
- Review of supporting documentation (e.g., labeling, design verification, clinical study design, etc.) to assure alignment with global regulatory strategy.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Other duties as assigned.
- Remote work option available.
- Ability to travel, up to 10%, as business and local policies allow.
Must Have Qualifications
- Bachelors degree and a minimum of 7 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
- Or, advanced degree and a minimum of 5 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
Desired/Preferred Qualifications
- Master’s Degree or Doctorate in scientific/engineering fields and related medical device-oriented disciplines (e.g. Regulatory Affairs)
- Critical thinking and creative problem solving
- Technically savvy: must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical / logistical issues
- Clear communicator, able to break down highly technical information with stakeholders of various backgrounds and functional responsibilities to find a common understanding
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
- Able to participate effectively in multiple workstreams with different goals and expectations. Capable of meeting the needs of teams in a timeline-dependent environment
- Experience with technical presentations and/or education sessions
- Product experience with software medical devices and quality systems
- Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
- Experience with regulatory submissions, such as IDEs, Original PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files, 30-day Notices, and Real Time Reviews
- Regulatory Affairs Certification (RAC)
- Professional skill level with writing and presentation tools, such as Microsoft Word, Excel, Office, PowerPoint, and Adobe software
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
Salary ranges for U.S (excl. PR) locations (USD):$114,400.00 - $171,600.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
About Medtronic
Medtronic benefits and compensation plans
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
At Medtronic, most positions are posted on our career site for 3-7 days.
