Related skills
jira regulatory submissions iso 13485 510(k) smartsheets📋 Description
- Lead end-to-end product development programs across assay, software, and systems
- Manage cross-functional dependencies with R&D, manufacturing, quality
- Translate strategy into executable program roadmaps and milestones
- Support regulatory activities: design controls and filings
- Align external partnerships and internal stakeholders; governance
- Drive on-time, within-budget delivery across multiple projects
🎯 Requirements
- 3-5+ years in program management in biotech or diagnostics
- Experience with regulated environments (IVD/medical devices)
- Strong knowledge of ISO 13485 and IEC 62304
- Experience with regulatory submissions (IDE, 510(k), PMA)
- PMP or equivalent certification preferred
- Excellent executive communication and stakeholder influence
🎁 Benefits
- Medical, dental, vision, life and disability coverage
- Free testing for employees and families; fertility care
- Pregnancy and baby bonding leave
- 401(k) and commuter benefits
- Employee referral program
- Career growth and development opportunities
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