Hybrid Senior Regulatory Affairs Role for SaMD Governing Compliance

Transform regulatory challenges into solutions as a Senior Regulatory Affairs Specialist! This hybrid opportunity empowers you to oversee the global compliance of Software as a Medical Device (SaMD).

In this dynamic role, you will lead major regulatory submissions and collaborate with diverse teams to ensure compliance across various jurisdictions. Your input will be crucial in defining regulatory strategies and driving product enhancements while safeguarding quality standards in the medical device sphere.

Key Responsibilities

• Support development of regulatory requirements for SaMD products
• Manage key submissions including 510(k) and CE Dossiers
• Advise product teams on compliance and market opportunities
• Ensure proper alignment with international standards
• Conduct internal audits and training sessions

Requirements

• Bachelor's in a relevant discipline; advanced degree is a plus
• 5–7+ years of regulatory affairs experience in SaMD
• Proven expertise in FDA and EU regulatory environments
• Strong knowledge of compliance standards
• Excellent project management and communication skills

Lead the way in regulatory affairs, ensuring that our medical devices meet essential compliance standards for global markets.