Regulatory Affairs Manager

Regulatory Affairs ManagerCareers 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.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 Lung Health and Gynecologic products within the Surgical organization. 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: Lafayette, CO; Mounds View, MN; North Haven, CT; or Mansfield, MA.Responsibilities may include the following, as well as other duties that may be assigned:Oversee the day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team.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.Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.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 seven years of relevant experience or an advanced degree with a minimum of five years of relevant experience.Preferred Qualifications:Five or more years of medical device regulatory affairs experience.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 RequirementsThe 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 & SponsorshipAt 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.Recruitment Fraud AlertWe 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 View email address on click.appcast.io & CompensationMedtronic 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 - $181,200.00This 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,