We anticipate the application window for this opening will close on - 20 Mar 2026

 

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

If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist.
Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries.
The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally.

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

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections

• Leads or compiles all materials required in submissions, license renewal and annual registrations

• Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes

• Write, update and maintain technical documentation

• Review promotional material for accuracy and compliance

• Keeps abreast of regulatory procedures and changes

• May direct interaction with regulatory agencies on defined matters

• Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

• Bachelor’s degree required

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

Nice to Have

• Experience in the medical device industry

• Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)

• Excellent attention to details, proactive approach and ability to work independently

• High learning agility and ability to work under pressure

• Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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.
 

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