Regulatory Affairs Specialist

Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

The Regulatory Affairs Specialist supports international regulatory strategies and submission activities across global markets. This role is responsible for assisting with new product registrations, renewals, amendments, and other country-specific regulatory requirements to help ensure compliance and maintain market access. The Regulatory Affairs Specialist works closely with regional regulatory colleagues and cross-functional teams, including Quality, Clinical, Manufacturing, and Marketing, to support submission readiness, coordinate documentation, and contribute to timely execution. This is an on-site position and may be based in North Haven, CT; Lafayette, CO; Mansfield, MS; or Mounds View, MN. The role supports global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA, while helping track timelines, identify submission risks, respond to health authority questions, and support the lifecycle management of regulated products.

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

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Compile materials required for global submissions, license renewals, amendments, and responses to health authority inquiries.
• Assess regulatory requirements and help recommend appropriate submission strategies based on business needs, risk, and timelines.
• Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities.
• Review regulatory, technical, quality, labeling, and product documentation for completeness, accuracy, and consistency.
• Manage multiple projects simultaneously while tracking deadlines, action items, and submission status to support timely execution.
• Identify regulatory risks, gaps, and delays early and escalate issues as needed to support resolution.
• Communicate regulatory requirements clearly to internal and external stakeholders to support informed decision-making.
• Stay current with regulatory procedures, guidelines, and changes in global requirements.
• Apply sound judgment to support regulatory activities, collaborate with stakeholders, and assist team members as needed.
• Maintain awareness of evolving global regulatory requirements and communicate relevant updates to internal teams.
• Support continuous improvement by identifying opportunities to streamline submission processes, trackers, and cross-functional ways of working.

Must Have: Minimum Requirements

• Bachelor's degree required
• Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.

Nice to Have

• Experience with U.S. FDA and international regulatory requirements for medical devices
• Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
• Experience supporting regulatory submissions, audits, or inspections
• Strong written and verbal communication skills
• Strong organizational skills with the ability to manage multiple priorities
• Experience collaborating in a cross-functional, fast-paced environment
• Familiarity with medical device product development or lifecycle management
• RAC certification or progress toward certification
• Experience working with Notified Bodies or global regulatory agencies.

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. 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.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

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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):$74,400.00 - $111,600.00

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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.