Regulatory Device Specialist

Revance • Johnson City, TN

15h

About The Position

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.

Requirements

• Minimum of 3 years Medical Device Regulatory Experience required
• 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 formats, including FDA 510(k), EU MDR 2017/745 Technical Documentation, IMDRF/STED Table of Contents, and ASEAN CSDT submissions.
• Working knowledge of MDSAP, UKCA, and Notified Body review processes, and of country-specific labeling, translation, and UDI/registry requirements.
• Ability to manage multiple concurrent international submissions across time zones

Nice To Haves

• aesthetics experience preferred
• Bachelor’s degree from a four year college or university.

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.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO (12 days' PTO), holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level