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

A Day in the Life

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for working collaboratively to plan and carry out regulatory activities related to the Basic Energy and Access and Instrument product portfolio. This role involves preparing and submitting regulatory documents, such as 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting the implementation of the EU Medical Device Regulation (MDR). The Sr. RAS translates regulatory requirements into actionable project or product requirements and works closely with multiple departments to ensure that all regulatory deliverables are completed accurately and on schedule. The position is best suited for individuals who have comprehensive experience across the entire regulatory life cycle of medical devices, as well as a strong background in reviewing advertising and promotional materials for medical devices. Initially, the role will focus on regulatory sustaining activities, with the possibility of new product development responsibilities being added in the future.

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

• Provide strategic and technical regulatory guidance to support design and manufacturing sustaining covering both domestic and international requirements.
• Prepare 510(k) submissions , change notices and updates to technical documents to support CE marking and other global product registrations as necessary
• Interact and negotiate with regulatory authorities during product development and review processes.
• Share business and product information with international regulatory teams to inform strategy and communicate requirements to the business team.
• Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
• Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
• Review and approve promotional and advertising materials for compliance.
• Stay up-to-date on domestic and international regulatory requirements, guidelines, and standards.
• Participate in internal and external audits as required.
• Maintain regulatory documentation to ensure compliance.
• Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
• Lead or compile materials for submissions, license renewals, and annual registrations.
• Monitor regulatory procedures and changes.
• Interact directly with regulatory agencies on defined matters as needed.
• Contribute to continuous improvement initiatives and process optimization within RA
• Perform additional duties as assigned.

Must Have: Minimum Requirements

• Bachelors degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry OR a Masters degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.

Nice to Have

• Knowledge of FDA and EU MDR requirements
• Experience of working with all classification of product in the U.S and/or EU.
• Design Dossier and/or Technical Documentation experience
• Technical Writing
• International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR)
• Product Labeling requirements and standards
• May have practical knowledge of project management
• Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.

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.

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):$92,000.00 - $138,000.00

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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.