We anticipate the application window for this opening will close on - 5 Aug 2025

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

Job Summary: Principal Regulatory Affairs Specialist

As a Principal Regulatory Affairs Specialist you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized by Digital Technologies. You will lead regulatory strategy development submissions and approvals for international market access ensuring alignment with international regulatory requirements (RF non-medical and medical). In collaboration with cross-functional teams you will work to expand Medtronics presence in global markets by navigating complex regulatory landscapes and driving successful product registrations.

Key Responsibilities:

Develop and implement regulatory strategies for RF and software enabled medical devices to achieve timely product approvals.
Prepare submit and manage regulatory filings across global regulatory agencies based on FDA and EU submissions.
Provide expertise on RF-related regulatory requirements and standards (e.g. FCC IEC ISO etc.).
Partner with global regulatory teams to facilitate market expansion and product registrations in new regions.
Monitor and interpret global regulatory trends and provide guidance to internal stakeholders.
Collaborate with R&D Quality and other teams to ensure product compliance throughout the lifecycle.
Support audits inspections and regulatory interactions as needed.
Qualifications:

Strong knowledge of RF technologies and related regulatory standards.
Proven experience in global regulatory submissions and product approvals.
Excellent communication and leadership skills to influence cross-functional teams.
Ability to navigate complex regulatory environments and provide strategic guidance.

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
• Leads or compiles all materials required in submissions license renewal and annual registrations.
• Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

SPECIALIST CAREER STREAM:Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy:Recognized expert managing large projects or processes .
Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager .
Coaches reviews and delegates work to lower level specialists.

Organizational Impact:Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results .
May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity:Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation .
Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area.
Implements solutions to problems.

Communication and Influence:Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels .
May negotiate with others to reach understanding or agreement and influence decision-making.

Leadership and Talent Management:Typically provides guidance coaching and training to other employees within job area.
Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.

Required Knowledge and Experience:Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience.
May have broad knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.

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.

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):$118400.00 - $177600.00

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 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.