Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid)
Must Have (minimum requirements)
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s degree.
- Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry
- Or advanced degree with a minimum of 5 years of Regulatory Affairs experience within the medical device industry
Desired/Preferred Qualifications
- Direct Regulatory Affairs experience supporting programs throughout software development life cycle.
- Medical device industry experience with Class II/III/IV products.
- Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc.,) and associated regulatory filings in the U.S., EU, and globally.
- Experience performing advertising and promotion reviews/approvals for medical devices.
- Experience engaging regulatory bodies.
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Analytical, process and data visualization experience
- Working knowledge of Project Management methodologies and tools; PMP certification is an asset.
- Demonstrated strong business acumen and planning.
- Strong interpersonal, quantitative analysis, and problem-solving skills.
- High degree of initiative and influence management skills
- Excellent written and oral communication, technical writing, and editing skills.
- Experience working in a virtual team environment in supporting cross-functional teams remotely.
- Results oriented. Ability to drive to completion in adherence to aggressive project schedules.
- Ability to manage multiple projects and proficiency with Microsoft Office and software tools.
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, recruiter 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 here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
