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About the role
Key responsibilities & impact- Serving as the regulatory affairs lead on cross‑functional teams
- Driving regulatory strategy and execution for Tier 1, high‑volume markets
- Conducting global regulatory change assessments
- Leading or supporting regulatory filings for continuity and lifecycle projects
- Providing regulatory review and input on technical documentation and reports
- Communicating regulatory outcomes and technical information to cross‑functional teams
- Supporting risk management, vigilance reporting, and other quality‑related initiatives
- Supporting the implementation of key corporate initiatives and enabling tools
Requirements
What you’ll need- Bachelor’s Degree or higher (completed and verified prior to start)
- Ten (10) years in regulatory affairs experience in the drug and/or medical device industry
- Experience authoring regulatory submissions and technical documentation for drug and medical device products
- Experience supporting regulatory activities in EMEA, APAC, and LATAM
- Experience revising, reviewing, and approving product labeling, including marketing claims
- Experience with dental products, including NDA and OTC monograph drugs and medical devices
- Experience supporting design control verification and validation activities for medical devices
- Experience applying regulatory knowledge through cross-functional project management
Benefits
Comp & perks- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyregulatory filingsregulatory submissionstechnical documentationrisk managementvigilance reportingdesign controlverificationvalidationproduct labeling
Soft Skills
communicationcross-functional collaborationleadershipproject management
Certifications
Bachelor’s Degree