Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices
Perform Regulatory Impact Assessments to determine registration implications for proposed product and design changes
Prepare and submit international regulatory filings in alignment with established timelines and business objectives
Lead and author 510(k) submissions, including applicable technical and regulatory content
Represent Regulatory Affairs on cross-functional projects and provide regulatory guidance throughout development and change management
Collaborate with internal teams to implement and improve regulatory processes, including registration tracking, reporting, and status management
Monitor global regulatory changes and assess their impact on submission strategies and existing registrations
Interact with regulatory authorities as needed during submission and review processes
Coordinate with international partners on product changes, regulatory notifications, and license maintenance
Author or revise SOPs to support ongoing quality system and regulatory compliance
Support audit readiness and other regulatory or quality-related initiatives as assigned

8+ years of regulatory affairs experience with a Bachelor’s degree, or 6+ years with a Master’s or advanced degree in a related field
Proven experience leading and authoring 510(k) and/or EU MDR submissions
Strong familiarity with global medical device regulations, including 21 CFR 820 (QMSR), EU MDR/MDD, CMDR, APAC, and LATAM
Demonstrated understanding of ISO 13485, ISO 14971, MDSAP, GSPR, GDPR, HIPAA, and related international standards
Strong written and verbal communication skills, including experience authoring regulatory submission content
Experience completing Regulatory Impact Assessments and supporting Quality Management Systems
Willingness to travel up to 5 percent as needed for audit support

Multiple high-quality medical plan options with substantial employer contributions
Health coverage starting day one
Short-term and long-term disability and life insurance
401(k) with immediate employer match vesting
Annual reimbursement for professional memberships
Conference attendance and continued learning opportunities
Self-managed PTO and 10 paid holidays
Monthly internet stipend
Company-issued laptop and one-time home office setup stipend
Fully remote work environment with virtual events and yearly retreats

Senior Regulatory Affairs Specialist

Key skills