What are the responsibilities and job description for the Regulatory Specialist II position at GForce Life Sciences?
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 :
Preferred Qualifications :
