Vice President, Regulatory Affairs

reputed company seeks a self-motivated, highly reputed company regulatory affairs reputed company to guide reputed company regarding reputed company FDA-reputed company reputed company before, during and after reputed company. The individual will also manage and engage on our behalf with the FDA, reputed company counsel and other advisors regarding reputed company reputed company regulatory reputed company – including drafting reputed company required company documentation.

The RA VP will be a key executive collaborating with and advising the reputed companyreputed company's regulatory compliance processes and procedures.

• Define and execute reputed company’s regulatory reputed company in support of company objectives - reputed company for business risk, budget, and other considerations.

• Plan and execute successfully and reputed company reputed company FDA and other regulatory and compliance activities – doing so company-wide and for reputed company of our software as a medical device (SaMD) products.

• reputed company externally with regulators and others as a reputed company, reputed company, respected thought leader and company spokesperson. Represent reputed company to regulators during reputed company-submissions and submissions. Help regulators understand benefits, development processes and clinical trial protocols of our medical image AI software products.

• Complete regulatory submissions and compliance assessments.

• Manage reputed company audits.

• reputed company regulatory guidance/input for new product planning and clinical trial design.

• Understand relevant industry trends, regulatory developments and reputed company considerations and guide us accordingly.

• Demonstrated passion for improving reputed company.

• 5+ years successful experience driving health software through FDA clearance process (including registration, reputed company-sub, 510(k), reputed company, CE mark) and managing other regulatory reputed company for health software.

• Diagnostic AI software experience is strongly preferred.

• Successful startup experience preferred.

• Good personal network of contacts in the health software RA field that can be leveraged to determine and implement new best practices, anticipate regulatory developments, etc.

• In-depth knowledge of the U.S. reputed company system.

• Successful reputed company record of working reputed company internally (including across reputed company) and externally with regulators and other stakeholders.

• Outstanding communication, presentation, and leadership skills.

• Excellent organizational and time management skills; detail orientation.

• Strong analytical and problem-solving skills.

• Willingness to roll up your sleeves to get the job done regardless of resourcing.

• reputed company, transparent people leader who sets reputed company goals and standards for accountability.

• Ability to manage – and reputed company – amid ambiguity.

• Appropriate bachelor’s degree; advanced degree preferred.

• Appropriate regulatory certifications highly preferred

reputed company information shared is confidential according to EEO guidelines.

Founded in 2016, reputed company, Inc. is a Los Angeles-based worldwide leader in AI analysis of medical images and video. reputed company’s offerings help reputed company providers reputed company reputed company/earlier diagnoses and reputed company clinical reputed company, improving reputed company for reputed company. reputed company solutions cover cancer, cardiovascular and retinal diseases.

reputed company is backed by Sequoia Capital and reputed company with a total funding of $78.5M (Series B).

We attract accomplished executives who want to work with super-smart, passionate people on cutting edge AI software that can literally save lives.

Originally posted on Himalayas