Overview
Skills
Job Details
Sr. Regulatory Specialist SaMD / 510(k) / Medical Device
Location: Remote - (Philadelphia, PA must work in EST time zone)
Duration: Long Term Contract
About the Role:
We are seeking a Senior Regulatory Specialist with deep expertise in Software as a Medical Device (SaMD) and 510(k) submissions to support regulatory strategy and compliance for next-generation digital health and AI-enabled medical products.
This role will partner closely with cross-functional teams (R&D, Quality, and Clinical) to ensure regulatory compliance across the full product lifecycle from design and development through post-market surveillance.
Key Responsibilities:
Serve as the Regulatory Affairs lead on cross-functional project teams, providing strategic input and technical guidance on SaMD and medical device regulatory pathways.
Prepare, author, and manage Traditional and Special 510(k) submissions, Q-Submissions, and related filings.
Develop, review, and maintain technical documentation (CERs, RMFs, DMRs, DHRs, labeling, and technical files).
Ensure compliance with FDA regulations (21 CFR 11, 820, 803, 806) and ISO/IEC standards (ISO 13485, ISO 14971, IEC 62304, IEC 82304-1).
Evaluate product changes, labeling updates, and new features for regulatory impact and implement required actions.
Collaborate with Quality and Engineering teams to define risk management, validation, and verification strategies.
Support internal and external regulatory audits, inspections, and authority interactions (FDA, EU Notified Bodies).
Assist in SOP development, regulatory documentation updates, and compliance reviews for AI/ML-enabled digital health products.
Ensure timely submission and compliance for post-market requirements, adverse event reporting, and product lifecycle maintenance.
Required Skills & Qualifications:
Bachelor s degree in a relevant discipline (Engineering, Life Sciences, or Regulatory field).
10+ years of experience in Regulatory Affairs within the Medical Device or Digital Health (SaMD) industry.
Proven hands-on experience preparing and submitting 510(k) submissions (Traditional, Special, and Q-Sub).
Solid knowledge of FDA QSR (21 CFR 820, 11) and ISO 13485, ISO 14971, and IEC 62304 standards.
Understanding of MDR 2017/745, MDCG 2019-11, and global device classification systems.
Experience with Class I, II, and III medical devices.
Strong understanding of risk management, technical documentation, and design control.
Excellent written and verbal communication skills, with the ability to collaborate across teams.
Preferred Skills:
Experience with AI/ML or connected device regulatory submissions.
Exposure to cybersecurity risk management for SaMD.
Familiarity with Veeva Vault, MasterControl, or TrackWise.
RAPS membership or RAC certification preferred.
Why Join:
Work on cutting-edge AI and digital health products redefining patient outcomes.
Collaborate directly with global regulatory and engineering leaders.
Competitive hourly rate and long-term growth potential with a Fortune 500 client.
To Apply:
Submit your updated resume highlighting 510(k), SaMD, and FDA regulatory experience.
(Only candidates located in the EST time zone will be considered.)