Manager, Regulatory Submissions

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Formulating and spearheading worldwide regulatory strategies to align with business goals

• Overseeing and supporting submissions and communication with global regulatory bodies, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, among others

• Creating processes to effectively meet the requirements of various regulatory frameworks on a large scale

• Designing and implementing premarket and postmarket regulatory project plans and strategies, including evaluations of change controls

• Collaborating closely with cross-departmental subject matter experts to facilitate the development of documentation necessary for regulatory applications and internal records

• Partnering with business leadership to ensure that the regulatory strategy is in line with commercial objectives

• Regularly reporting to our executive team, swiftly operationalizing leadership directives

⛳️ Requirements

• Experience in Oncology IVD, IUO, and CDx is essential

• Familiarity with intricate medical devices, including a combination of: Genomics NGS Software and AI-based devices, Clinical decision support software, and Oncology

• Proficient in: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements outside the US, CE Marking, UKCA registration, and performance studies as mandated under IVDR and MDR

• Knowledge in software validation and risk management

• Understanding of cybersecurity in medical devices

• Awareness of machine learning validation requirements

• Experience in lifecycle management of medical devices/IVDs

• Knowledge of alterations to medical devices or IVDs, including those that necessitate reporting or regulatory submissions

• Familiarity with relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA

• Excellent communication, presentation, and interpersonal skills

• Ability to lead cross-functional teams of subject matter experts

• Experience working in a startup-like environment

• Capability to interact effectively with regulators

• Ability to collaborate well with quality, clinical, medical, bioinformatics, and laboratory teams across diverse therapeutic areas

• Responsive to feedback, adaptable to change direction, and capable of identifying innovative solutions to address business and regulatory requirements

• Exceptional attention to detail

• Strong project management abilities and capacity to execute project plans in a dynamic environment

• A scientific background, with a PhD preferred

• At least 5+ years of experience in Regulatory Affairs concerning medical devices

• Familiarity with engineering principles and biology, with the ability to assess device performance data and develop testing plans

🏝️ Benefits

• Incentive compensation

• Restricted stock units

• Medical and other benefits based on the position