A team of seasoned experts united around a mission-critical objective — addressing complex global market challenges through advanced technology.
We are looking for an FDA consultant with experience in 21 CFR Part 820, ISO 13485, ISO 14971 for documentation preparation, presales support, and client guidance through FDA approval.
Requirements: * 3+ years of experience preparing or managing FDA-compliant documentation for medical devices or SaMD. * Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971. * Experience with software medical device documentation. * Hands-on experience preparing Design Controls, Risk Management, and V&V documents. * Ability to interpret regulatory requirements and convert them into structured documentation tasks. * Experience collaborating with external regulatory experts or client-side FDA consultants. * Excellent English communication and strong attention to detail. * Experience in outsourcing or consulting environments is a plus.
Your responsibilities: * Lead the creation, organization, and maintenance of FDA-required documentation on our side. * Ensure alignment of all documentation with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and software-related standards. * Collaborate with engineering, QA, product, and business analysis teams to ensure documentation accuracy and completeness. * Lead preparation and maintenance of: →Design Controls documentation. →Risk Management File. →Software V&V documentation (plans, protocols, reports). →Software classification and safety artifacts. →DHF-related components owned by our team. * Coordinate with the client’s FDA/regulatory consultant to ensure our documents fit submission expectations. * Review internal artifacts for consistency, traceability, and compliance. * Support internal audits, document reviews, and readiness checks. * Provide guidance to internal teams on documentation best practices and FDA expectations.
Why join Empeek? ✨ * Challenging & meaningful products — complex architectures, modern technologies, and solutions that truly make an impact. * Professional growth — personal development plan, mentorship, career maps, and opportunities to grow into new roles and responsibilities. * Strong team culture — we share the same mission, values, and passion for what we do. * Flexibility & ownership — freedom to choose your format and schedule, focus on results, and have a real impact on the company’s success.
You’re also welcome to recommend colleagues or friends — we offer a referral bonus
