Medit
Senior Manager, Regulatory & Quality Affairs
Base pay range: $165,000.00/yr - $185,000.00/yr
Medit is a global leader in 3D dental imaging and digital dentistry, with a $2B valuation and customers in over 100 countries. As we continue to grow across North and Latin America, we are seeking a senior‑level RA/QA expert to own and lead our regional compliance strategy.
The Opportunity This role covers both
medical device hardware
and
Class II SaMD (software as a medical device) . You will take full ownership of regulatory and quality operations across the U.S., Canada, and LATAM – including FDA Class II 510(k) submissions, ISO 13485 quality systems, and regulatory leadership for both physical devices and software platforms. You’ll collaborate directly with our global HQ in Korea and operate with a high degree of autonomy.
What You’ll Own Regulatory Strategy & Submissions
Lead and manage Class II regulatory submissions including FDA 510(k), Health Canada, ANVISA, and LATAM filings for both hardware and software
Serve as U.S. and LATAM regulatory liaison with global HQ and local authorities
Monitor evolving regulations and proactively adjust strategy across jurisdictions
Quality System Ownership
Ensure ongoing compliance with ISO 13485, MDSAP, and QSR requirements
Own and maintain quality assurance systems, CAPAs, SOPs, and change control
Support audits and inspections from FDA, Health Canada, and other regulators
Cross-Functional Leadership
Work closely with R&D, product, legal, and support teams to ensure regulatory alignment
Guide internal teams on regulatory best practices and QA processes
Represent Medit in external conversations with regulatory bodies and partners
What We’re Looking For
7–10+ years of experience in Regulatory Affairs and Quality Assurance, ideally with both medical devices and digital health products
Demonstrated success leading FDA Class II 510(k) submissions, especially for SaMD
Strong knowledge of ISO 13485, MDSAP, QSR, and related standards
Experience operating independently in cross‑border environments (U.S., Canada, LATAM)
Proven ability to make decisions and drive compliance without heavy oversight
Excellent project management and documentation skills
Bachelor’s degree required; advanced degree or RAC certification a plus
English fluency required; Spanish or Portuguese preferred.
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other
Industries: Medical Equipment Manufacturing
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Medit is a global leader in 3D dental imaging and digital dentistry, with a $2B valuation and customers in over 100 countries. As we continue to grow across North and Latin America, we are seeking a senior‑level RA/QA expert to own and lead our regional compliance strategy.
The Opportunity This role covers both
medical device hardware
and
Class II SaMD (software as a medical device) . You will take full ownership of regulatory and quality operations across the U.S., Canada, and LATAM – including FDA Class II 510(k) submissions, ISO 13485 quality systems, and regulatory leadership for both physical devices and software platforms. You’ll collaborate directly with our global HQ in Korea and operate with a high degree of autonomy.
What You’ll Own Regulatory Strategy & Submissions
Lead and manage Class II regulatory submissions including FDA 510(k), Health Canada, ANVISA, and LATAM filings for both hardware and software
Serve as U.S. and LATAM regulatory liaison with global HQ and local authorities
Monitor evolving regulations and proactively adjust strategy across jurisdictions
Quality System Ownership
Ensure ongoing compliance with ISO 13485, MDSAP, and QSR requirements
Own and maintain quality assurance systems, CAPAs, SOPs, and change control
Support audits and inspections from FDA, Health Canada, and other regulators
Cross-Functional Leadership
Work closely with R&D, product, legal, and support teams to ensure regulatory alignment
Guide internal teams on regulatory best practices and QA processes
Represent Medit in external conversations with regulatory bodies and partners
What We’re Looking For
7–10+ years of experience in Regulatory Affairs and Quality Assurance, ideally with both medical devices and digital health products
Demonstrated success leading FDA Class II 510(k) submissions, especially for SaMD
Strong knowledge of ISO 13485, MDSAP, QSR, and related standards
Experience operating independently in cross‑border environments (U.S., Canada, LATAM)
Proven ability to make decisions and drive compliance without heavy oversight
Excellent project management and documentation skills
Bachelor’s degree required; advanced degree or RAC certification a plus
English fluency required; Spanish or Portuguese preferred.
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other
Industries: Medical Equipment Manufacturing
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