Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives

Responsibilities

• Partners with regional and functional subject matter experts to define, align, and execute global regulatory advocacy strategies and action plans, establishing enterprise positions, advocacy priorities, and coordinated engagement across all geographies, including regulator education opportunities.
• Leads the development of relevant white papers and talking points that can be utilized in global regulatory advocacy work by drafting content and soliciting comments from internal stakeholders, and work with appropriate team members and stakeholders to develop presentations for advocacy to regulators.
• Leads commenting for external documents, including relevant guidances and regulation, and participate in external working groups, as directed.
• Identifies and supports the development of internal resources (e.g., playbooks, tools, training, and subject matter expert networks) to enable enterprise-wide, globally harmonized regulatory advocacy.
• Leads and manages internal working groups, initially focused on priority global harmonization and regulatory policy initiatives, to provide structured opportunities for OU, functional, and regional stakeholders to collaboratively develop, shape, and evolve enterprise advocacy priorities.
• May direct interaction with regulatory agencies on defined matters and engage with industry associations and other stakeholders to influence global regulatory policy development.
• Collaborates with regional and cross-functional teams on emerging or region-specific regulatory challenges and translates enterprise advocacy strategy into targeted, issue-specific advocacy actions.
• Keeps abreast of industry trends and emerging regulatory issues impacting Medtronic's business and regulatory environment.
• Works with project manager to maintain and update the Global Regulatory Policy SharePoint, including providing summaries of key policy updates, identifying commenting opportunities, and maintaining advocacy trackers to support regulatory advocacy efforts.
• Leverages regulatory experience with technical domains to inform regulatory policy and support broader submission regulatory strategy, as needed.

Minimum Qualifications

• Bachelor's degree
• 7+ years of experience within the medical device industry or a regulatory agency with a bachelor's degree or 5+ years of experience within the medical device industry or a regulatory agency with an advanced degree

Preferred Qualifications

• Proven experience leading complex, cross-functional and geographically dispersed working groups or teams, with responsibility for defining scope, governance, and deliverables and for facilitating effective 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 the following technical regulatory topics: postmarket surveillance, MDSAP, clinical evidence, or human factors
• Clear written, verbal and visual communication skills, with the ability to synthesize complex regulatory information into white papers or presentations.
• Excellent relationship-building and collaboration skills across levels and geographies; ability to engage internal and external experts.
• Ability to deal with ambiguity and changing environments, to learn quickly and teach others; flexible and able to adapt to shifting priorities.
• Self-starter mindset with a passion for continuous learning, process improvement, and functional excellence.
• Flexible work hours to accommodate global stakeholders.