Regulatory Affairs Specialist - Advocacy Software & Cybersecurity (Diabetes Group)
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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)
Must Have; Minimum Requirements
- Bachelor’s Degree (Engineering or scientific discipline, such as biology, chemistry or physics)
- Minumum 2 years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
- Or 0 years of experience with an advanced degree
Nice To Have
- 2+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Master’s degree.
- Master’s Degree or Doctorate in scientific/engineering fields and related medical device-oriented disciplines (e.g. Regulatory Affairs)
- 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.
- Critical thinking and creative problem solving
- Experience with technical presentations and/or education sessions
- 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 in assembling facts from various areas, analyzing data, and providing informed recommendations
- 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
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)
