R-545307: Regulatory Affairs Strategist, Globalization (EMEA - Europe, META)
$137,500–$220,100 year
On-siteConcord, North Carolina, United States
Job Summary
Provide centralized regulatory governance for the registration assessment process, interpreting global requirements to enable compliant growth and market access. Develop and standardize global regulatory registration assessments to drive consistency, efficiency, and scalability across regions while accommodating local needs. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling implementation of global processes and coordinating networks across teams for the eIPRRA process. Identify common pain points, escalate issues, and build communication channels to harmonize key processes. Requires 8+ years in the medical device industry with 5+ in Regulatory Affairs, with 25% travel. 4 days of in-office presence required.
Required Qualifications
- Bachelor's degree in science, engineering, or technology discipline
- Minimum 8 years of experience in the medical device industry
- At least 5 years in Regulatory Affairs
- Must have the ability to stand, walk and sit
- Must have the ability to talk or hear, both in person and by telephone
- Must have the ability to use hands to finger, handle or feel objects or controls
- Must have the ability to reach with hands and arms
- Ability to travel US and OUS travel ~25%
- Minimum of 4 days of in-office presence per week
- Employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Master's degree in business, management, or technology related field
- Experienced Business and/or Regional roles
- Regulatory Affairs Certification (RAC)
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