We anticipate the application window for this opening will close on - 1 Sep 2025
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.

MUST HAVE: MINIMUM REQUIREMENTS

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s degree required with 0 years of regulatory affairs or related experience
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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.

• Develop proficiency in domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
• 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 new product submissions, license renewals and change submissions.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• 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.
• Provide regulatory input for design and manufacturing, including review of specifications, protocols and reports, engineering change notices, technical files, nonconforming materials, product complaints, and product failure analysis.
• Prepare and track submissions for FDA and global regulatory agencies, including registration documents, progress reports, supplements, and amendments.
• Act as liaison with Medtronic China regulatory personnel to address questions and issues that arise as part of the registration and/or testing process.
• Obtain and maintain CFGs including the notarization and legalization, EC/ISO certificates and various other regulatory documents.
• Participate in compliance activities that relate to the department and the company as a whole.
• Perform other regulatory affairs duties when requested.