Senior Regulatory Affairs Specialist
About the role
For our client, we are seeking a Senior Regulatory Affairs Specialist to join the team of a leader in the Telecommunications & Hardware space. This role will help drive regulatory readiness across a portfolio of connected products, with a focus on maintaining compliance, streamlining documentation, and supporting market access. The specialist will partner closely with cross-functional teams to improve QMS processes, strengthen submission workflows, and support international registrations. This position is well suited for someone who can balance detailed regulatory execution with broader commercialization and compliance goals in a highly regulated environment. Location: Remote - US based candidates only, no visa sponsorship available.
Responsibilities
- Lead QMS and regulatory remediation efforts to streamline workflows
- Revise and consolidate SOPs to support compliance with FDA and ISO standards
- Drive cleanup of regulatory documentation and maintain submission databases
- Inform global registration strategies for international markets
- Manage Notified Body interactions for technical reviews and compliance updates
- Support regulatory evaluations for new market launches
- Standardize review processes across commercial and life sciences teams
Qualifications
- Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field
- 5-8+ years of regulatory affairs experience in medical devices or digital health
- Strong knowledge of FDA 21 CFR 820/QMSR, EU MDR, ISO 13485, and global submissions
- Experience with 510(k)s, Q-Subs, De Novo submissions, and Notified Body interactions
- Proven success leading QMS remediation and market entry initiatives
- Strong communication and organizational skills
Benefits
- Opportunity to impact the health of millions through innovative products
- Generous paid time off
- Stock incentive plans available
- Comprehensive medical, dental, vision, and life insurance
- One Medical membership for personal health care
- Parental leave for family support
- 401k matching for retirement savings
- Learning and development stipend to foster employee growth
Pay
Compensation: $138,000 – $192,000 annually