Senior Regulatory Affairs Specialist
Job Summary
Leading regulatory strategy for innovative digital health solutions, the full-time Senior Regulatory Affairs Specialist will oversee global regulatory compliance, manage documentation processes, and support international market expansion in a remote setting.
Key responsibilities
- Lead architectural QMS and regulatory remediation, aligning global procedures into streamlined workflows
- Manage interactions with Notified Bodies and oversee regulatory documentation cleanup for global submissions
- Serve as the RA representative on core project teams for hardware and AI/software releases
Required qualifications
- Bachelor's or Master's/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or a related field
- 5-8+ years of regulatory affairs experience in medical devices, digital health, and/or SaMD
- Strong knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, and ISO 13485
- Experience writing/submitting 510(k)s, Q-Subs, and managing Notified Body reviews
- Proven track record in leading QMS remediation programs and global market entries
Complete Job Description
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