Principal Regulatory Affairs Specialist (Boston)

We anticipate the application window for this opening will close on - 5 Jul 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**

As a **Principal Regulatory Affairs Specialist** at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide.

**Key Responsibilities:**

+ Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations.

+ Lead or perform coordination and preparation of regulatory documentation for submissions, internal audits, and regulatory inspections.

+ Compile and manage submission materials for new approvals, license renewals, and annual domestic and international product registrations.

+ Recommends changes to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance.

+ Monitor, evaluate, and enhance regulatory tracking and control systems for continuous improvement.

+ Stay current on evolving global regulatory requirements, procedures, and standards.

+ Directly interface with regulatory authorities as needed on defined topics.

+ Participate in and support internal and external audits.

+ Review and provide guidance on promotional and advertising materials to ensure compliance with regulatory standards.

+ Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other international regulatory frameworks.

+ Demonstrate leadership and collaboration skills in a team environment, including coaching and mentoring of team members.

+ Successfully manage multiple priorities while maintaining a strong problem-solving mindset and effective decision-making capabilities.

+ Drive successful regulatory submissions and approvals in both the U.S. and EU markets.

**Must Have: Minimum Qualifications**

+ Bachelor’s Degree with a minimum of 7 years of relevant experience **OR**

+ Advanced degree with a minimum of 5 years of relevant experience

**Nice to Have: Preferred Qualifications**

+ 7+ years of medical device regulatory affairs with roles showing increasing responsibility.

+ Strong leadership and team management skills.

+ Excellent communication and interpersonal skills.

+ Ability to thrive in a fast-paced, collaborative environment.

+ Experience with Notified Body audits.

+ RAC credential preferred.

+ Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”.

+ Ability to analyze and resolve non-routine regulatory issues using independent judgment.

+ Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations.

+ Proven ability to create or revise departmental procedures to enhance operational efficiency or align with evolving regulatory requirements.

+ Experience working with a range of medical device classifications and technologies.

+ Demonstrated expertise in developing regulatory strategies that support timely approval of clinical trial applications.

**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):$118,400.00 - $177,600.00

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 ( \_name=signon&co\_num=30601&co\_affid=medtronic)

**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.

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.

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, d