Prin Regulatory Strategy Spec
About The Position
The Principal Regulatory Strategy Specialist is an individual contributor within Global Regulatory Affairs responsible for supporting and partnering with Regulatory teams across the organization as they shape and advance regulatory strategies aligned with Medtronic’s business goals and objectives. This role will partner closely with operating unit teams to provide additional expertise and guidance on complex, novel, and strategically important regulatory questions across the product lifecycle, including supporting effective due diligence for acquisitions. This role will help teams assess options, anticipate obstacles, and develop practical, risk-based pathways for innovative technologies across Medtronic, including but not limited to software-enabled products. The role will also provide consultation to operating unit teams involved in mergers, acquisitions, licensing, and integration activities across product portfolios. This position is expected to operate with a high degree of independence, influence without direct authority, and convert insights into enterprise value through internal best practices and educational support for regulatory professionals and cross-functional partners. This is a unique opportunity to contribute across Medtronic’s diverse and cutting edge portfolio.
Requirements
- Bachelor's degree
- Minimum of 7 years of experience within the medical device industry or a regulatory agency with a bachelor's degree or a master’s degree with a minimum of 5 years of relevant experience.
Nice To Haves
- Experience developing or advising on global regulatory strategies, pathways, and evidence approaches for complex, high-risk, or novel technologies where precedent may be limited or evolving.
- Experience supporting medical device submissions and health authority interactions.
- Working knowledge of software and AI-enabled medical devices, including software lifecycle management, documentation, risk management, validation, maintenance, and change control.
- Experience providing regulatory input to teams involved in mergers, acquisitions, licensing, or integration activities.
- Direct experience working for a regulator, particularly in a scientific review role.
- Demonstrated ability to translate changing regulatory expectations into practical internal guidance or educational content.
- Strong analytical judgment, with the ability to balance business objectives, regulatory requirements, patient impact, and execution risk.
- Strong collaboration and influence skills, with the ability to build trust across businesses, functions, and geographies.
- Knowledge of product development, clinical strategy, quality systems, manufacturing, and post-market requirements for medical devices.
- Advanced degree in a technical, scientific, or engineering area
- RAC certification or similar credential is a plus.
- 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.
Responsibilities
- Partner with operating unit regulatory teams to help develop and refine strategies for complex medical devices, novel technologies, significant product changes, and market expansion opportunities.
- Provide strategic input on regulatory pathways, intended use, claims, evidence expectations, risk management, and post-market commitments.
- Support regulatory authority interactions by helping frame key questions, review briefing materials, contribute to response strategies, and communicate positions clearly and credibly.
- Advise on software and digital-health regulatory strategy, including software lifecycle expectations, AI-enabled functionality, interoperability, and connected systems.
- Serve as an enterprise advisor to operating unit regulatory teams conducting M&A, integration, or remediation activities by helping identify potential regulatory opportunities, risks, relevant internal process considerations, and applicable cross-portfolio precedent.
- Translate regulatory intelligence regarding evolving global regulations, guidance, policy, and deficiency trends into practical implications for Medtronic business regulatory strategies.
- Identify recurring strategic issues and deficiency trends across operating units to inform training content.
- Synthesize complex technical and regulatory issues into clear recommendations for senior leaders, regulatory teams, and cross-functional partners.
Benefits
- 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
- Simple Steps (global well-being program)
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
