Principal Regulatory Affairs Specialist: Pelvic Health
Medtronic
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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 ā 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
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As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Missionāto alleviate pain, restore health, and extend lifeāwe develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.
Pelvic Health
Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomesāhelping improve confidence, independence, and quality of life.
Check us out on LinkedIn: Medtronic Pelvic Health
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At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Weāre working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.āÆ
Prefer a candidate located in the Minneapolis area or who can relocate there.
We are looking for a passionateĀ PrincipalĀ Regulatory Affairs SpecialistĀ with experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTAs) for our innovative, high-risk medical device portfolio.Ā Ā Ā
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Role OverviewĀ
TheĀ PrincipalĀ RegulatoryĀ Affairs Specialist developsĀ globalĀ regulatoryĀ strategiesĀ and leadsĀ worldwideĀ clinical trialĀ applicationsĀ forĀ high-riskĀ medicalĀ devices.Ā Ā They willĀ manageĀ strategy meetings andĀ submissions to the FDA and EMA (under the EU MDR),Ā discuss with the Notified Body,Ā andĀ coordinateĀ with internationalĀ regulatory partners forĀ global approvals.Ā Ā Ā Additionally, the specialist develops and executes strategies for new product introductions and lifecycle changes.Ā
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Responsibilities may include the following and other duties may be assigned.
ĀGlobal Clinical Trial Submissions:āÆDevelop, prepare, and manage high-quality clinical trial regulatory dossiers (e.g., IDEs in the US, CTAs in Europe/MDR,Ā ITA in Canada) to obtain approval forĀ initiatingĀ clinical studies worldwide.Ā
Regulatory Strategy:āÆDefine and execute global regulatory strategies for high-risk (Class III) devices, providing guidance on pre-clinical and clinical data requirements.Ā
Agency Interaction:āÆAct as the direct liaison between the company and Regulatory Authorities (FDA, Notified Bodies) or with in-countryĀ regulatory partners (Competent Authorities, Health Canada, TGA, etc.)Ā regardingĀ trial applications, amendments, and annual reports.Ā
Regulatory Intelligence:āÆMonitor, analyze, and communicate changes in global regulations (e.g., EU MDR,Ā FDA, Health Canada, TGA, etc.) affecting clinical research and device development.Ā
Cross-Functional Collaboration:āÆPartner with Clinical Affairs, R&D, Quality, and Marketing to review clinical protocols, informed consent forms, and investigator brochures for compliance with GCP and local requirements.Ā
Technical Documentation:āÆAuthor and review regulatoryĀ submissionĀ technical dossiers, design history files, and clinical evaluation reports (CERs).Ā
Product support and maintenance:Ā SupportĀ pre- and post- market regulatory activities forĀ high-riskĀ medical devices, including:Ā
Ensuring regulatory compliance (e.g., clinical trial audits, site registrations, device approvals, vigilance reporting, and recalls).Ā
Supporting the development and review of marketing, advertising, and promotional materials.Ā
Providing feedback and regulatory guidance to product development teams.Ā
Managing regulatory support for marketed products, including labeling reviews and change control documentation.āÆĀ
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Ā Must Have:Ā MinimumĀ RequirementsĀ
Bachelorās degree inĀ life science, engineering, or a relatedĀ field
Minimum 7Ā yearsĀ of relevant experience, or an advanced degree withĀ 5+Ā yearsĀ of experience.Ā Ā
Nice To HaveĀ
7-10Ā yearsĀ of industry experience, with at leastĀ 4-5+Ā yearsĀ in regulatory,Ā clinical, or quality roles.Ā
ProvenĀ track recordĀ ofĀ successfulĀ high-risk medical deviceĀ clinical trialĀ applicationsĀ (e.g., IDE, ITA, CTA)Ā worldwide.Ā Ā
Advanced degreeĀ in a scientific, health, or engineering discipline.Ā
Expert knowledge of global clinical trial authorization regulations, regional risk classifications, and ISO 14155 (GCP) standards.Ā
Experience with real-world evidence (RWE), AI/ML applications, or digital health technologies.Ā
Experience in claim developmentĀ and/orĀ performing advertising and promotion reviews for class IIIĀ /PMA medical devices.Ā
Exposure to reimbursement/market access strategies.Ā
History of successful device submissionsĀ in aĀ US Class IIIĀ PMA environment.Ā
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.āÆ
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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Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:Ā
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Ā
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.Ā
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.Ā
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 AskHR@medtronic.com.Ā
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Benefits & Compensation
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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.Ā We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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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,Ā Health Savings Account,Ā Healthcare Flexible Spending Account,Ā Life insurance, Long-term disability leave,Ā Dependent daycare spending account,Ā Tuition assistance/reimbursement, andĀ Simple Steps (global well-being program).
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The following benefits and additional compensation are available to all regular employees:Ā Incentive plans, 401(k) plan plus employer contribution and match,Ā Short-term disability,Ā Paid time off,Ā Paid holidays,Ā Employee Stock Purchase Plan,Ā Employee Assistance Program,Ā Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andĀ Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
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Regular employees are those who are not temporary, such as interns.Ā 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.
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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. (āMedtronicā) 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 findĀ 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.
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