Company: The Steely Group
Location: San Jose, CA, United States
Type: Full-time | Regulatory Affairs
Salary: Competitive
About the Role
As a Regulatory Affairs Manager/Director, you will prepare regulatory FDA submissions for client products, including pre-submissions, while working closely with cross-functional teams to ensure timely execution of projects.
Key Responsibilities
- Prepare and submit 510(k), PMA, and De Novo regulatory submissions to the FDA
- Engage with R&D, Quality Assurance, and Clinical Affairs teams to gather data for submissions
- Develop and implement global regulatory strategies
- Monitor regulatory changes and advise on compliance requirements
Requirements
- Minimum 5 years of experience in regulatory affairs (8+ years overall industry experience)
- Comprehensive knowledge of ISO 13485:2016, ISO 14971:2019, and 21 CFR 820
- Proven track record of successful FDA 510(k) submissions
- Bachelor’s degree in science, engineering, or related field
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