Regulatory Device Specialist

Position Summary:

The Regulatory Device Specialist prepares and submits high quality routine regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. They will also support the preparation, review and archival of electronic and paper regulatory submissions ensuring compliance with FDA and other Health Authorities, company policies and procedures under the guidance of regulatory management.

This position serves as a subject matter expert on various domestic and foreign regulations for medical devices.

• Reports to:
  
  Regulatory Affairs Manager
• Location:
  
  Remote with occasional travel
• Salary: *$65,000-$73,000 annually + annual performance bonus

* The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location.

• Prepare pre-market submission reports / technical files per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU, APAC, Middle East).
• Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
• Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission).
• Assist in the update, enhancement, and creation of internal policies and procedures.
• Supports regulatory compliance to QSR, ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.
• Compile, submit, and manage international product registrations, license renewals, and registration amendments, including FDA 510(k) s, Health Canada Medical Device Licences, EU MDR Technical Documentation, UKCA, TGA (Australia), PMDA (Japan), ANVISA (Brazil), NMPA (China), MFDS (South Korea), COFEPRIS (Mexico), SFDA (Saudi Arabia), and MOHAP (UAE).
• Prepare and manage export and country-specific documentation, including Certificates to Foreign Government (CFG), Certificates of Free Sale, Declarations of Conformity, ISO 13485/MDSAP certificates, and Letters of Authorization, and coordinate notarization, apostille, legalization, and consularization as required.
• Assess new market opportunities by determining device classification, registration pathway, submission content, expected timelines, and in-country representation requirements; provide registration strategy input to new product launch and market entry plans.
• Review labeling, Instructions for Use, and promotional materials for country-specific content, symbols, translation, and UDI requirements, and support product data submissions to GUDID, EUDAMED, and other national registries.
• Support Notified Body, MDSAP, and international regulatory inspections and audits, including preparation of requested documentation and follow-up on findings and nonconformities.
• Monitor and interpret evolving global regulations and guidance (e.g., EU MDR, UKCA transition, IMDRF harmonization initiatives), assess business impact, and communicate required actions to cross-functional stakeholders.
• Perform other duties as assigned.

• Minimum of 3 years Medical Device Regulatory Experience required; aesthetics experience preferred
• Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and EU MDR requirements
• Demonstrated experience obtaining and maintaining medical device registrations in at least three major markets outside the United States (e.g., EU, UK, Canada, Australia, Japan, China, Brazil, LATAM, Middle East, or APAC).
• Hands-on experience authoring or compiling regulatory dossiers in multiple…