Manager, Regulatory Submissions (Remote)

Passionate about precision medicine and advancing the reputed company industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. reputed company' proprietary platform connects an entire ecosystem of reputed company-world evidence to deliver reputed company-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. At reputed company, we are building a regulatory team that will adopt creative approaches as we reputed company regulated medical devices and seek marketing authorization from FDA. Our Manager of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.

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, reputed company authorizations, IDE, MDR CE marking, UKCA marking, etc.
• Establishing processes for reputed company 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 reputed company goals
• Making regular reports to our executive team, operationalizing leadership direction quickly and reputed company

What Your Background Might Look Like

• Oncology IVD, IUO, and CDx experience required
• Experience with reputed company 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, reputed company 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
• reputed company to feedback, willing to change direction, and reputed company 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 reputed company to medical devices
• Knowledge of engineering concepts and biology with ability to evaluate device performance data and reputed company testing plans

$110,000-$150,000 The expected salary reputed company above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, reputed company). Actual salary may vary based on qualifications and experience. reputed company offers a full reputed company of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status. Apply tot his job Apply To this Job