Sr Regulatory Affairs Manager at Medtronic Singapore

Lafayette, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Sep, 26

Salary

231600.0

Posted On

06 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Global Product Approvals, Lifecycle Management, US FDA Regulations, EU MDR, Team Leadership, Cross-functional Collaboration, Regulatory Submission Preparation, Risk Mitigation, Post-market Compliance, Strategic Thinking, Decision-making

Industry

Medical Equipment Manufacturing

Description

We anticipate the application window for this opening will close on - 8 Jun 2026 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 Manager, Regulatory Affairs is responsible for leading the development and execution of global regulatory strategies to support worldwide product approvals and lifecycle management for the Acute Care and Monitoring (ACM) Shiley™ airway product portfolio. This role provides strategic leadership for regulatory activities supporting product development, commercialization, and post-market compliance, with particular focus on the US and EU and supports to rest of the world. The Senior Manager leads a team of regulatory professionals and works across a highly matrixed organization to develop and align regulatory strategies with business objectives. This role partners closely with R&D, Quality, Clinical, Marketing, and Operations to ensure regulatory requirements are effectively integrated into product development and lifecycle management activities. The ACM Operating Unit is committed to excellence in innovation and commercialization to advance our vision and long-term business growth. The ACM operating unit is evolving its product delivery, innovation, and commercialization approaches to strengthen product leadership across the portfolio and enable product development excellence across ACM. This position requires onsite presence four(4) days per week at our Lafayette, Colorado location. Responsibilities may include the following and other duties may be assigned. Regulatory Strategy Leadership Lead the development and execution of global regulatory strategies supporting new product development, product modifications, and lifecycle management across the ACM Shiley™ airway product portfolio. Provide strategic regulatory guidance to cross-functional teams to support business objectives and enable successful product commercialization. Anticipate regulatory risks and develop mitigation strategies to support timely approvals and market access. Ensure regulatory considerations are integrated into product development, clinical, and commercialization strategies. Organizational and Team Leadership Lead, develop, and mentor a team of regulatory professionals responsible for global regulatory activities. Establish clear objectives, provide coaching and feedback, and foster a high-performance and accountable team culture. Identify and develop key talent while supporting career development across all levels of the organization. Promote a safe, inclusive, and collaborative work environment. Regulatory Agency Engagement Provide leadership for interactions with the US FDA and EU Notify Body related to regulatory strategy and submission reviews. Guide the submission strategy development, preparation, and review of regulatory submissions and ensure high-quality regulatory documentation. Support regulatory agency meetings and negotiations to facilitate product approvals. Cross-Functional Collaboration and Governance Partner with R&D, Quality, Clinical, Marketing, and Operations to ensure regulatory alignment across product programs and lifecycle activities. Provide regulatory leadership for new product registrations, product modifications, technology transfers, and acquisition activities. Ensure compliance with applicable global regulatory requirements and standards, including U.S. FDA regulations and EU MDR. Provide regulatory input to labeling, promotional review, manufacturing changes, and clinical activities to ensure compliance. Operational Excellence and Business Alignment Monitor regulatory progress against program milestones and provide updates to senior leadership. Drive continuous improvement of regulatory processes, tools, and communication pathways. Ensure effective planning and prioritization of regulatory activities across the team to support business objectives. Required Knowledge and Experience: Bachelor’s Degree with and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience. Nice to Have: 10+ years of medical device regulatory affairs experience Significant experience in medical device regulatory affairs supporting global product development and commercialization. Strong knowledge of U.S., EU, and international regulatory requirements, including EU MDR. Experience leading interactions with US FDA and other regulatory agencies, including regulatory meetings and submission strategy discussions. Demonstrated ability to lead cross-functional initiatives within a complex, matrixed organization. Proven track record of leading high‑performing regulatory teams Strong communication, strategic thinking, and decision-making skills. 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. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. 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):$154,400.00 - $231,600.00 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 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, 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 setting is 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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Responsibilities

Lead the development and execution of global regulatory strategies for the ACM Shiley airway product portfolio to support worldwide approvals and lifecycle management. Manage a team of regulatory professionals and collaborate with cross-functional partners to ensure compliance with US FDA and EU MDR requirements.