Job Title: Regulatory Affairs Specialist II

100% on-site in Alameda, CA

Must be able to work on a W2

6-month contract

Job Summary:

The Regulatory Affairs Specialist will be responsible for preparing and managing regulatory submissions to USFDA and OUS regulatory authorities, with a focus on medical devices and digital health technologies. The role involves conducting regulatory assessments, ensuring compliance with US medical device regulations, and maintaining clear communication with cross-functional teams and stakeholders. The ideal candidate will bring expertise in software-related medical device regulations, digital health, and experience with international submissions. This role requires strong documentation skills, regulatory knowledge, and the ability to effectively collaborate across teams.

Job Responsibilities:

• Prepare and submit regulatory submissions to USFDA and OUS regulatory authorities.
• Perform regulatory assessments, documentation, and due diligence for medical devices and digital health technologies.
• Collaborate with cross-functional teams to address regulatory requirements and stakeholder inquiries.
• Ensure compliance with US medical device regulations, particularly software-focused devices and digital health.
• Maintain detailed records, regulatory documentation, and responses to support compliance efforts.

Job Qualifications:

• Bachelor’s degree in science, engineering, or medical fields.
• 3+ years of experience in Regulatory Affairs within the medical device industry.
• Strong understanding of US medical device and software regulations (no pharma experience).
• Experience with regulatory submissions for software as a medical device and digital health technologies.
• Excellent verbal and written communication skills to interact with cross-functional teams and stakeholders.

Preferred Qualifications:

• Experience with 510(k) submissions.
• Familiarity with EU and international medical device regulations.
• Knowledge of mobile medical labs software.