Regulatory Affairs Project Specialist

Regulatory Affairs Project Specialist

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

At Medtronic, our mission is to alleviate pain, restore health, and extend life for patients worldwide. As a Regulatory Affairs Project Specialist, you will play a crucial role in maintaining ongoing product compliance by assessing changes to existing medical devices and ensuring all necessary regulatory actions are executed. Your responsibilities will include evaluating the impact of product changes, preparing and submitting regulatory filings, and maintaining comprehensive documentation in line with global regulatory requirements. You'll be part of a collaborative, diverse, and innovative team that values integrity, inclusion, and a commitment to making a meaningful impact in healthcare. This role provides the opportunity to directly contribute to improved patient outcomes while advancing your career within a purpose-driven organization.

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

• Directs and coordinates the preparation of document packages for regulatory submissions, internal audits, and inspections
• Leads or compiles all required materials for submissions, license renewals, and annual registrations.
• Assesses proposed changes to products, processes, or labeling to determine regulatory impact.
• Monitors and improves tracking systems for regulatory projects.
• Stays current with regulatory procedures and changes in relevant markets.
• Leads cross-functional teams (R&D, Quality, Manufacturing, Clinical) to gather information needed for change assessments and regulatory filings.
• Coordinates and prepares regulatory filings for submission to global health authorities, including FDA and Notified Bodies.
• Maintains accurate and up-to-date regulatory documentation for all sustaining activities.
• Monitors regulatory requirements and guidance to ensure ongoing compliance for relevant markets.
• Supports audits and inspections related to sustaining regulatory activities.
• Provides regulatory input and guidance throughout the product lifecycle.

Must Have : Minimum Requirements

Bachelors degree required

Minimum of 2 years of relevant experience, or a Master's degree with a minimum of 0 years relevant experience.

Nice to Have

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.

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) : $73,600.00 - $110,400.00 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 :

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 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.