À propos de ce poste Principal Regulatory Affairs Specialist chez Medtronic
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
This position is located in Lafayette, CO or Mounds View, MN and supports Robotics Surgery Technologies (RST) in the Surgical Operating Unit.The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the consumable product [CB2.1]portfolio within RST. This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities as well as supporting complex post-market release and sustaining change activities.
This position is suited for a high-performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business and portfolio goals, drives regulatory strategy, and contributes to critical project and business milestones. The role requires strong awareness of cross-functional and organizational initiatives and the ability to assess regulatory impact on business decisions.
The Pr. RAS regularly communicates with internal stakeholders to provide strategic input, share updates, and support informed decision-making. Serving as a regulatory subject matter expert and individually contributing leader, this role acts as a role model within the organization and may mentor or provide guidance to junior regulatory professionals or support staff as needed.
Position requires to be onsite 4 days per week in one of the following locations:
• Lafayette, CO
• Mounds View, MN
Responsibilities may include the following and other duties may be assigned.
- Lead and execute global regulatory strategies across the product lifecycle, including early development and business wind-down activities.
- Provide regulatory strategy input for early-stage development, including pathway assessment, classification, and data requirements.
- Serve as a strategic partner to R&D, marketing, clinical, operations, and leadership to integrate regulatory considerations into product and business decisions.
- Act as regulatory lead for advertising and promotional material review, providing strategic guidance on claims, risk communication, and compliant promotional approaches.
- Lead or oversee preparation of U.S. and EU regulatory submissions, and support submissions for global markets.
- Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities to ensure compliance and support business objectives.
- Monitor and interpret global regulatory requirements and changes, proactively communicating risks and opportunities to stakeholders.
- Support and lead regulatory agency interactions, audits, inspections, and CAPA activities, as appropriate.
- Develop and deliver regulatory training; mentor junior regulatory staff.
Must Have: Minimum Requirements
- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
Nice to Have
- Extensive experience in medical device regulatory affairs.
- Strong hands-on experience with U.S. Class II and III medical devices, including applicable regulatory requirements and consensus standards.
- In-depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993-1.
- Proven experience authoring and leading U.S. regulatory submissions (e.g., 510(k), PMA, IDE) and EU Technical Documentation and change notifications.
- Demonstrated expertise in compiling and maintaining EU MDR Technical Documentation.
- Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets.
- Strong experience reviewing and advising on advertising and promotional materials for U.S. and EU markets.
- Demonstrated ability to develop and execute regulatory strategies that support business and product objectives.
- Collaborative, solution-oriented professional with a strong focus on delivering value to stakeholders and the organization.
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.
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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.
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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].
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.
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
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.
