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. You’ll 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 Medtronic's 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 /