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.