Manager, Regulatory Submissions (Remote)
Core
Developing and leading global regulatory strategies to support the development of regulated medical devices and seek marketing authorization from FDA and global authorities.
Role type
Manager, Regulatory Affairs (Medical Devices)
Builds
Regulated medical devices (Oncology IVD, IUO, CDx, Genomics, NGS, AI-based devices, Clinical decision support software)
Domain
Healthcare / Precision Medicine / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Oncology IVD/IUO/CDx experience, Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements, Ex-US CE Marking, UKCA registration, performance studies under IVDR and MDR, Software validation, risk management, Cybersecurity in medical devices, Machine learning validation requirements, Lifecycle management of medical devices/IVDs, Knowledge of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA, Engineering concepts, Biology, Device performance data evaluation, Testing plan development
Preferred skills
PhD, Scientific background
Technologies
Genomics, NGS, Artificial Intelligence, Clinical decision support software
Responsibilities
Developing and leading global regulatory strategies, Leading and assisting with submissions and correspondence with global regulatory authorities, Establishing processes for addressing requirements of multiple regulatory frameworks at scale, Developing and executing premarket and postmarket regulatory project plans, Working closely with cross-departmental subject matter experts to guide documentation creation, Making regular reports to the executive team
Seniority
Manager, hands-on IC