Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives
$120,000–$180,000 year
On-siteFridley, Minnesota, United States
Job Summary
Monitor, interpret, and influence evolving global regulatory policies to advance harmonization for medical device regulations. Partner with regional subject matter experts to define global advocacy strategies, establish enterprise positions, and coordinate engagement across all geographies. Lead the development of white papers, talking points, and presentations for regulatory advocacy, while managing external working groups and commenting on relevant guidances. Direct interaction with regulatory agencies and industry associations to shape global policy development, and collaborate with cross-functional teams to translate enterprise strategy into targeted issue-specific actions. Maintain the Global Regulatory Policy SharePoint, update advocacy trackers, and identify commenting opportunities.
Required Qualifications
- Bachelor's degree
- 7+ years of experience within the medical device industry or a regulatory agency with a bachelor's degree
- 5+ years of experience within the medical device industry or a regulatory agency with an advanced degree
- 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
- U.S. work authorization at the time of hire and for the duration of employment
Desired 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
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