Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives

Medtronic • Fridley, MN

15d • $120,000 - $180,000 • Onsite

About The Position

Medtronic’s Global Regulatory Affairs team is seeking a skilled contributor to its Clinical Research, Medical Science, and Regulatory Affairs Organization. The role supports global regulatory advocacy and policy strategy, with a primary focus on advancing harmonization of medical device regulations. It monitors, interprets, and influences evolving global regulatory policies; develops advocacy positions and supporting materials; and provides guidance to internal stakeholders on regulations and emerging issues. The position works with regional subject matter experts and cross-functional teams in a fast-paced, geographically dispersed environment to help shape the regulatory landscape and support patient access to safe, effective, and innovative medical technologies.

The role is onsite at a U.S.-based Medtronic facility, with a preference for working Eastern Time hours. Medtronic requires a minimum of four days onsite per week. Flexible hours may be needed to accommodate global stakeholders.

The position requires a bachelor’s degree and at least seven years of experience in the medical device industry or a regulatory agency with a bachelor’s degree, or at least five years with an advanced degree. The salary range is $120,000–$180,000, and the role is eligible for the Medtronic Incentive Plan. Benefits are available according to the employee eligibility terms stated in the posting.

Requirements

• Bachelor’s degree.
• At least 7 years of experience within the medical device industry or a regulatory agency with a bachelor’s degree, or at least 5 years of experience in those areas with an advanced degree.
• For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Ability to work onsite at a U.S.-based Medtronic facility at least four days per week.

Nice To Haves

• Experience leading complex, cross-functional, geographically dispersed working groups or teams, including defining scope, governance, and deliverables and facilitating collaboration and decision-making.
• Demonstrable understanding of international regulatory requirements, guidelines, and policy.
• Experience in regulatory advocacy related to healthcare policy and regulations.
• Experience with technical regulatory topics such as postmarket surveillance, MDSAP, clinical evidence, or human factors.
• Clear written, verbal, and visual communication skills, including the ability to synthesize complex regulatory information into white papers or presentations.
• Strong relationship-building and collaboration skills across levels and geographies, with the ability to engage internal and external experts.
• Ability to manage ambiguity and changing environments, learn quickly, teach others, and adapt to shifting priorities.
• Self-starter mindset and interest in continuous learning, process improvement, and functional excellence.
• Flexible work hours to accommodate global stakeholders.
• Preference for working Eastern Time hours.

Responsibilities

• Partner with regional and functional subject matter experts to define, align, and execute global regulatory advocacy strategies and action plans, establish enterprise positions and priorities, coordinate engagement across geographies, and identify regulator education opportunities.
• Lead development of white papers and talking points for global regulatory advocacy, including drafting content and soliciting internal stakeholder comments; work with relevant team members and stakeholders to develop presentations for regulator advocacy.
• Lead commenting on external documents, including relevant guidance and regulations, and participate in external working groups as directed.
• Identify and support development of internal resources such as playbooks, tools, training, and subject matter expert networks to enable globally harmonized regulatory advocacy across the enterprise.
• Lead and manage internal working groups focused initially on priority global harmonization and regulatory policy initiatives, providing structured forums, charters, and expectations for stakeholders to develop and evolve enterprise advocacy priorities.
• Direct interactions with regulatory agencies on defined matters as applicable, and engage with industry associations and other stakeholders to influence global regulatory policy development.
• Collaborate with regional and cross-functional teams to address emerging or region-specific regulatory challenges and translate enterprise advocacy strategy into targeted advocacy actions.
• Monitor industry trends and emerging regulatory issues affecting Medtronic’s business and regulatory environment.
• Work with a project manager to maintain and update the Global Regulatory Policy SharePoint, including summarizing policy updates, identifying commenting opportunities, and maintaining advocacy trackers.
• Apply regulatory experience and technical-domain knowledge to inform regulatory policy and support broader submission regulatory strategy as needed.

Benefits

• Competitive salary and flexible benefits package.
• Eligible for the Medtronic Incentive Plan (short-term incentive).
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance or reimbursement.
• Simple Steps global well-being program.
• Incentive plans.
• 401(k) plan with 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal