Regulatory Affairs Manager

Medtronic plc; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Tuition assistance/reimbursement

Job summary

Medtronic plc is seeking a Regulatory Affairs Lead to guide regulatory strategies for medical devices across the product lifecycle in the United States. You will oversee regulatory activities, collaborate with cross-functional teams, and interact with regulatory authorities to support submissions and approvals.

The role emphasizes building a high-performance team, talent development, and ensuring compliance with global regulations including the EU MDR and FDA interactions.

Qualifications

• Bachelor’s degree is required.
• Minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 of relevant experience.

Responsibilities

• May serve as the regulatory lead for one or more new product development projects.
• Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team, with potential for people management.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives and collaborate across a matrixed organization.
• Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews.
• Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.

Skills

Regulatory affairs

Leadership

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree

Job description

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.

A Day in the Life

• May serve as the regulatory lead for one or more new product development projects.
• Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team, with the potential to assume direct people management responsibilities as business needs evolve.
• Become actively involved in daily operations to meet schedules or resolve complex problems.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, and collaborate across a matrixed organization to ensure the global success of products.
• Collaborate with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategies with business objectives.
• Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews.
• Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with all applicable regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
• Provide oversight of regulatory reviews of advertising and promotional materials to ensure that product claims and materials align with applicable local guidance and regulations.
• Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.
• Provide targeted career coaching and feedback; manage and develop team members at all levels of experience.
• Clearly identify and communicate talent differentiation, and ensure that development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations and support meaningful development activities.
• Cultivate a safe, inclusive, and engaging work environment.
• Provide periodic progress reports or presentations to senior management regarding OU product submission goals.
• Continuously improve operating mechanisms, communication pathways, and processes to increase efficiency.
• Direct or perform the coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
• Lead or compile all materials required for submissions, license renewals, and annual registrations.
• Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
• Monitor and improve tracking and control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Required Knowledge and Experience

Bachelor’s degree required. Minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 of relevant experience.

Preferred Qualifications

• Five or more years of medical device regulatory affairs experience.
• Experience serving as a Regulatory Affairs lead for new product development projects.
• Degree in engineering or an advanced degree.
• Proven track record of leading high-performing teams.
• Ability to recognize and develop key talent.
• Excellent knowledge of U.S., European, and international regulations, including the EU MDR, as well as standards applicable to products of all risk classifications.
• Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions.
• Proven ability to prioritize work, manage time effectively, and meet project deadlines.
• Ability to work effectively in dynamic, cross-functional team environments.
• 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. 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.

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.

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):$120,800.00 - $181,200.00

• 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
• Simple Steps (global well-being program)

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• 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)
• 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.

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.