About the Role:
As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. You will guide product teams through compliant design and commercialization and represent the company in high-stakes regulatory interactions. This role is critical as we scale our medical device offerings and strengthen our global regulatory posture.

Responsibilities:

Regulatory

• Support development of global regulatory requirements for new and existing SaMD products (e.g. FDA, EU MDR, UKCA, TGA, Health Canada, MDSAP jurisdictions)
• Serve as primary author and owner of major submissions, including 510(k), De Novo requests, CE Technical Documentation, UKCA dossiers, and global regulatory filings
• Advise Product leadership on regulatory pathways, classification, predicate selection, clinical evidence needs, and market expansion opportunities
• Support regulatory interactions with FDA, Notified Bodies, and other competent authorities

Standards & Compliance

• Ensure compliance with global medical device regulations and software standards (e.g. 21 CFR Part 820/11, EU MDR 2017/745, IEC 62304, IEC 62366-1, ISO 14971, IEC 82304-1, EU AI Act, etc.)
• Partner with Product teams to integrate regulatory requirements into development and lifecycle management
• Oversee regulatory aspects of software validation, cybersecurity documentation, clinical evaluation, and risk management

Technical Documentation & Labeling

• Own Regulatory Product Files and Technical Documentation
• Ensure audit-readiness of DHFs, cybersecurity files, clinical evaluations, and post-market surveillance documentation
• Review and approve labeling, claims, and marketing materials

Regulatory Intelligence & Risk Mitigation

• Monitor evolving regulatory landscapes and translate changes into strategic guidance
• Conduct gap assessments and lead remediation initiatives
• Evaluate regulatory risks and provide recommendations to leadership

Cross-Functional Leadership

• Serve as primary regulatory partner to Product, Engineering, Quality, Clinical, Legal, and Marketing
• Support clinical evidence strategies, risk analyses, verification/validation, and post-market surveillance

Audits & Inspections

• Support regulatory preparation for internal audits, FDA inspections, and Notified Body audits
• Support evidence gathering and CAPA remediation

Training, Mentorship & External Representation

• Provide regulatory training to internal teams
• Represent the company in regulatory workgroups and industry forums

Preferred Competencies:

• RAC (Global) or RAC (EU) certification preferred
• ISO 14971 certification preferred
• ISO 13485 certification preferred
• PMP certification preferred
• Knowledge of cybersecurity expectations
• Familiarity with clinical evaluation frameworks
• Proficiency with electronic QMS systems

Required Qualifications:

• 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

The above statements are intended to describe the general nature and level of work being performed by most people assigned to this job. They are not intended to be an exhaustive list of all duties and responsibilities and requirements.