New · posted Oct 22
Medtronic · Medical Devices
Regulatory Affairs Manager
- North Haven, CT
- Hybrid
- Full-time
- Manager
Closes Nov 4, 2026 · 13 days left
The role
We anticipate the application window for this opening will close on - 4 Nov 2026
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.
What you need
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 Qualificationsnice to have
- 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.
What you'll do
As the Regulatory Affairs Manager, you will be responsible for establishing strategies for worldwide product approval and submission activities, directly executing submission activities focused on the U.S. and EU, and ensuring regulatory compliance for products within the Surgical Operating Unit. The Regulatory Affairs Manager is expected to achieve results through hands-on leadership and the delegation of responsibilities to individual contributors. This role requires collaboration with business partners to develop regulatory strategies that support business goals and translate those strategies into work plans for the Regulatory Affairs teams.
This position requires working onsite four days per week at one of our Surgical locations: North Haven, CT (preferred), Lafayette, CO, Mounds View, MN or Mansfield, MA.
Responsibilities may include the following, as well as other duties that may be assigned.
- 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.
Pay and benefits
$120,800 – $181,200 a year
Employer providedMedtronic 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
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
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.
Health, dental and vision insurance
401(k) with employer contribution and match
Paid time off
Employee Stock Purchase Plan
Tuition assistance/reimbursement
Medtronic Incentive Plan (short-term incentive)
Where you'll work
North Haven, CTHybridOpen in Maps (opens in a new tab)
More jobs in North Haven, CTWorking conditions
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.
Equal opportunity, accessibility and legal noticesMedtronic's statements, word for word
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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.
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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US54 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,800 | — | $181,200 |
| All US (middle half) | $147,875 | $161,250 | $174,625 |
This role: Medtronic's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 315 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Medtronic's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 40 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- GMP and compliance7
- Regulatory submissions7
- Documentation and SOPs4
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Medtronic on Regulatory Jobs
- 23
- Open roles
- 18
- Distinct roles
- 10
- Locations
By discipline
- Quality15 65%
- Regulatory8 35%
By level
- Senior & Principal13 57%
- Associate & Specialist7 30%
- Manager3 13%
More roles at Medtronic
- View role
Regulatory Affairs Specialist
Lafayette, CO +3 moreAssociate & SpecialistMedical Devices$74K–$112K
- View role
Regulatory Affairs Specialist
Minneapolis, MNAssociate & SpecialistMedical Devices$74K–$112K
- View role
Regulatory Affairs Manager
Lafayette, CO +3 more · HybridManagerMedical Devices$121K–$181K
- View role
Principal Regulatory Affairs Specialist
Lafayette, CO +1 more · HybridSenior & PrincipalMedical Devices$120K–$180K
Similar Regulatory Affairs roles elsewhere
- View role
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device
AbbVieIrvine, CA · HybridManagerMedical Devices$125K–$237K
- View role
Senior Manager, Regulatory Affairs
IntuitiveSunnyvale, CAManagerMedical DevicesSalary not listed
- View role
Manager, Regulatory Affairs - Biomaterials
Johnson & JohnsonRaynham, MA +1 moreManagerMedical Devices$117K–$201K
- View role
Manager, Regulatory Affairs
iRhythmRemote, USManagerMedical Devices$127K–$165K
Regulatory Affairs Manager at Medtronic
Applications close November 4. $121K–$181K a year, employer provided.