Sr. Manager Global Regulatory Strategy
On-site · Johns Creek, Georgia, United States or Fort Worth, Texas, United States
Job Summary
Lead regulatory strategy development for global contact lens technologies, including new product development, lifecycle management, and BD&L activities. Own global regulatory pathways and classifications across priority jurisdictions (US FDA, EU MDR, China NMPA, Health Canada, Japan PMDA) with proactive health authority engagement and advisory interactions. Coordinate cross-functional teams from ideation through launch, translating early technical data into actionable regulatory plans; contribute to regulatory digital transformation with tools like Veeva RIM. Travel up to 10%.
Required Qualifications
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
Desired Qualifications
- Extensive experience in regulatory affairs for contact lens and vision care medical device products
- Demonstrated experience with global regulatory strategies for novel or first-in-class medical devices
- Familiarity with pediatric device regulatory requirements and clinical study design considerations
- Experience with Veeva RIM or equivalent regulatory information management systems
- Experience supporting BD&L regulatory due diligence is a strong plus
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