# Title Regulatory Affairs Specialist (FDA Medical Device Regulation) - REMOTE: Anywhere USA at Filmore

- Company: Filmore
- What the company does: Backed by 500 Global.
- Company website: https://filmorebody.com
- Type: Startups
- Level: Mid level
- Location: Remote (US)
- Work setup: Remote
- Posted: 2026-09-09
- Apply by: 2026-10-24
- Apply: https://uscareers-fujifilm.icims.com/jobs/38247/regulatory-affairs-specialist-%28fda-medical-device-regulation%29---remote%3a--anywhere-usa/job
- Page: https://www.1752.vc/careers/jobs/filmore-title-regulatory-affairs-specialist-fda-medical-device-regulation-remote/

## About the role

This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

## What they're looking for

- Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations
- Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations)
- Excellent leadership, communication, collaboration, team work and interpersonal skills
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
- Excellent computer and internet search skills
- Strong ability to multi-task and to meet business deadlines


Source: 1752vc Careers, https://www.1752.vc/careers/jobs/filmore-title-regulatory-affairs-specialist-fda-medical-device-regulation-remote/