Manager, Regulatory Submissions

Role Overview

• Developing and leading global regulatory strategies to support business objectives
• Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc.
• Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale
• Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls
• Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records
• Work closely with business leadership to ensure regulatory strategy aligns with commercial goals
• Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

Requirements

• Oncology IVD, IUO, and CDx experience required
• Experience with complex medical devices, such as some combination of: Genomics NGS Software and artificial intelligence based devices Clinical decision support software Oncology
• Experience with: 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 as required under IVDR and MDR
• Software validation and risk management
• Cybersecurity in medical devices
• Machine learning validation requirements
• Lifecycle management of medical devices/IVDs
• Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions
• Relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA
• Strong communication, presentation. and interpersonal skills
• Guiding cross-functional teams of subject matter experts
• Working in a startup-like environment
• Interacting with regulators
• Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas
• Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
• Excellent attention to detail
• Strong project management skills and the ability to execute on project plans in a fast-paced environment
• Scientific background PhD preferred.
• Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices
• Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans.

Tech Stack

• Cyber Security

Benefits

• incentive compensation
• restricted stock units
• medical and other benefits depending on the position