Regulatory Device Specialist
New
R
RevanceMedical Devices
Remote with occasional travelFull-TimeMiddle
Salary$65,000-$73,000 annually + annual performance bonus
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Job Details
- Experience
- Minimum of 3 years Medical Device Regulatory Experience
Requirements
- Bachelor’s degree from a four-year college or university.
- Minimum of 3 years of medical device regulatory experience.
- Demonstrated experience obtaining and maintaining registrations in at least three major international markets.
- Solid understanding of cGMP, ISO 13485, FDA, and EU MDR requirements.
- Hands-on experience authoring regulatory dossiers including FDA 510(k), EU MDR Technical Documentation, and ASEAN CSDT.
- Working knowledge of MDSAP, UKCA, and Notified Body review processes.
- Familiarity with UDI, labeling, translation, and international registry requirements.
- Ability to manage multiple concurrent international submissions across time zones.
- Experience with aesthetics products is preferred.
Responsibilities
- Prepare pre-market submission reports and technical files for FDA, Health Canada, EU, APAC, and Middle East agencies.
- Manage international product registrations, license renewals, and registration amendments including FDA 510(k)s and EU MDR Technical Documentation.
- Review and interpret FDA and international regulations to ensure sound product submissions.
- Conduct regulatory review of post-market product changes and determine appropriate change control mechanisms.
- Assess new market opportunities by determining classification, registration pathways, and providing strategy for product launches.
- Support Notified Body and international regulatory inspections and audits.
- Monitor global regulatory evolutions to assess and communicate business impact to stakeholders.
- Prepare and manage export documentation including Certificates to Foreign Government and Declarations of Conformity.
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