Principal Regulatory Affairs Spec Pelvic Health
Share
Job Location:
Minneapolis, MN - USA
Monthly Salary:
$ 120000 - 180000
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties.PRINCIPALREGULATORY AFFAIRS SPECIALIST Global Clinical Trials (High-Risk Devices)
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 outcomeshelping improve confidence independence and quality of life.
Check us out on LinkedIn: Medtronic Pelvic Health
Onsite
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Were 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.
We are looking for a passionatePrincipalRegulatory Affairs Specialistwhohas experiencedevelopingglobalregulatory strategies andleading worldwide Clinical Trial Applications (CTA)for our innovative high-risk medical device portfolio.
Role Overview
ThePrincipalRegulatoryAffairs Specialist developsglobalregulatorystrategiesand leadsworldwideclinical trialapplicationsforhigh-riskmedicaldevices.They willmanagestrategy meetings andsubmissions to the FDA EMA (under EU MDR)discussions with the Notified Bodyandcoordinateswith internationalregulatory partners forglobal approvals.Additionally the specialist develops and executes strategies for new product introductions and lifecycle changes.
Key responsibilities:
Global Clinical Trial Submissions:Develop prepare and manage high-quality clinical trial regulatory dossiers (e.g. IDEs in the US CTAs in Europe/MDRITA in Canada) to obtain approval forinitiatingclinical studies worldwide.
Regulatory Strategy:Define and execute global regulatory strategies for high-risk (Class III) devices providing guidance on pre-clinical and clinical data requirements.
Agency Interaction:Act as the direct liaison between the company and Regulatory Authorities (FDA Notified Bodies) or with in-countryregulatory partners (Competent Authorities Health Canada TGA etc.)regardingtrial applications amendments and annual reports.
Regulatory Intelligence:Monitor analyze and communicate changes in global regulations (e.g. EU MDRFDA Health Canada TGA etc.) affecting clinical research and device development.
Cross-Functional Collaboration:Partner 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.
Technical Documentation:Author and review regulatorysubmissiontechnical dossiers design history files and clinical evaluation reports (CERs).
Product support and maintenance:Supportpre- and post- market regulatory activities forhigh-riskmedical devicesincluding:
Ensuring regulatory compliance (e.g. clinical trial audits site registrations device approvals vigilance reporting and recalls).
Supporting the development and review of marketing advertising and promotional materials.
Providing feedback and regulatory guidance to product development teams.
Managing regulatory support for marketed products including labeling reviews and change control documentation.
Must Have:MinimumRequirements
Bachelors degree inlife science engineering or relatedfieldwith7yearsof relevant experience or an advanced degree with5yearsof experience.
Proventrack recordofsuccessfulhigh-risk medical deviceclinical trialapplications(e.g. IDE ITA CTA)worldwide.
Nice To Have
7-10yearsof industry experience with at least4-5yearsin regulatoryclinical or quality roles.
Advanced degreein a scientific health or engineering discipline.
Expert knowledge of global clinical trial authorization regulations regional risk classifications and ISO 14155 (GCP) standards.
Experience with real-world evidence (RWE) AI/ML applications or digital health technologies.
Experience in claim developmentand/orperforming advertising and promotion reviews for class III/PMA medical devices.
Exposure to reimbursement/market access strategies.
History of successful device submissionsin aUS Class IIIPMA environment.
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 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 lifewhere 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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 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 findhere 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.
Required Experience:
Staff IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
