Global Regulatory Device Specialist (Remote)

Revance Therapeutics, Inc.; United States; Remote; USD 65,000 - 73,000; Full time

Benefits offered by this job

Competitive compensation

Flexible PTO & holidays

Healthcare benefits & 401k

Job summary

Revance is seeking a Regulatory Device Specialist to prepare and submit high-quality regulatory submissions to the FDA and other health authorities. You will ensure compliance with applicable laws and company timelines, and serve as a subject matter expert on domestic and foreign regulations for medical devices.

This remote role with occasional travel reports to the Regulatory Affairs Manager and offers a salary of $65,000–$73,000 annually plus an annual performance bonus.

Qualifications

• Minimum 3+ years in medical device regulatory affairs.
• Experience with FDA, Health Canada, EU MDR and other authorities.
• Strong understanding of QSR, ISO 13485, and risk management.

Responsibilities

• 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.

Skills

Regulatory submissions

FDA submissions

Global regulatory knowledge

Dossier preparation

Notified Body knowledge

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Job description

Revance is seeking a Regulatory Device Specialist to prepare and submit high-quality regulatory submissions to the FDA and other health authorities. You will ensure compliance with applicable laws and company timelines, and serve as a subject matter expert on domestic and foreign regulations for medical devices.

This remote role with occasional travel reports to the Regulatory Affairs Manager and offers a salary of $65,000–$73,000 annually plus an annual performance bonus.