Regulatory Affairs Strategist, Globalization (Americas - US, Canada, LATAM)
$135,500–$216,800 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 and scalability across regions while maintaining local flexibility. Act as a strategic partner to Business Units and Regional leaders, coordinating the eIPRRA process and harmonizing key processes to identify common pain points and solutions. Stays apprised of global regulatory policy topics and escalates issues as needed to clarify ambiguous situations. Requires 8+ years in the medical device industry with 5+ years in Regulatory Affairs, plus 25% travel. Based in Franklin Lakes, NJ with 4 days in-office presence weekly.
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
- Ability to stand, walk and sit
- Ability to talk or hear, both in person and by telephone
- Ability to use hands to finger, handle or feel objects or controls
- Ability to reach with hands and arms
- Ability to operate standard office equipment and keyboards
- Ability to travel US and OUS travel ~25%
- Minimum of 4 days of in-office presence per week
- 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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