Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Senior Regulatory Affairs Specialist guiding the expansion of Software as a Medical Device (SaMD) portfolio. Collaborating with product teams and regulatory authorities to ensure compliance and efficient commercialization.
Responsibilities
- Serve as a regulatory lead expert supporting the expansion of Software as a Medical Device (SaMD)
- Guide product teams through compliant design and commercialization
- Support development of global regulatory requirements for SaMD products
- Own Regulatory Product Files and Technical Documentation
- Monitor evolving regulatory landscapes and translate changes into strategic guidance
Requirements
- Bachelor's degree in Life Sciences, Engineering, or Regulatory Science; advanced degree preferred
- 5–7+ years of regulatory affairs experience in SaMD (preferred) or medical device
- Demonstrated success leading FDA 510(k), De Novo, and EU MDR submissions
- Deep expertise in SaMD regulations and software standards
- Strong communication and project leadership skills
Benefits
- Medical, Dental, & Vision Plans
- 401(k)
- FSA/HSA
- Commuter Benefits
- Tuition Assistance Plan
- Vacation and Sick Time
- Paid Parental Leave
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