Manager, Regulatory Submissions (Remote)

Responsibilities

• 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
• Working 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, NGSSoftware 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
• 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
• Able 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

Qualifications

• 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

Skills

• Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

Pay

$110,000-$150,000

Schedule

The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience.

Benefits

We offer a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Company

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.