1d ago
Staff Global Regulatory GPO
United States
$140k-$170k / year
full-timelead Remotebiotech
๐ผ About This Role
You'll develop and execute global regulatory strategies for a leading diagnostics company, ensuring compliance across product lifecycle management. You'll oversee labeling and promotional material approvals while driving cross-functional initiatives that strengthen governance and audit readiness. This high-impact role offers flexible remote work within a global, innovation-driven organization.
๐ฏ What You'll Do
- Develop and execute global regulatory strategies for product lifecycle management.
- Oversee regulatory requirements for product labeling and global standards adherence.
- Manage regulatory review and approval of marketing, advertising, and scientific materials.
- Support internal and external audits, inspections, and global compliance reviews.
๐ Requirements
- Bachelor's degree with 9+ years, Master's with 7+ years, or Doctorate with 4+ years in life sciences or related field.
- Extensive regulatory affairs experience in in-vitro diagnostics, medical devices, or highly regulated industries.
- Strong ability to interpret global regulatory frameworks and apply them to product and business operations.
- Experience managing labeling, product registration, and regulatory lifecycle processes.
โจ Nice to Have
- Experience working in matrixed and multicultural environments.
- Presentation and stakeholder management skills across global, cross-functional teams.
- Proficiency in regulatory documentation systems.
๐ Benefits & Perks
- ๐ฐ Competitive salary $140,000โ$170,000 plus bonus.
- ๐ฅ Comprehensive medical, dental, and vision insurance.
- ๐๏ธ Paid time off and holidays.
- ๐ก Flexible remote work with occasional travel.
- ๐ Career development opportunities in a global life sciences organization.
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Panel Interviewยท 90 min
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