Senior Manager or Director-Regulatory at Manatt, Phelps & Phillips, LLP in New York, NY

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Description

Manatt Health integrates legal and consulting experience to better serve the complex needs of clients across the healthcare system. Combining legal excellence, firsthand experience in shaping public policy, sophisticated strategy insight and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 160 attorneys and consultants from Manatt, Phelps & Phillips, LLP, and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions and lead healthcare into the future. For more information, visit https://www.manatt.com/Health.

Position Overview:

Manatt Health is seeking a highly qualified senior manager or director with extensive regulatory expertise and in-depth knowledge and understanding of the U.S. Food and Drug Administration (FDA) Digital Health Program to become a part of our growing team. This is an exciting opportunity to be part of a nationally recognized healthcare strategy consulting team and work with clients that are passionate about improving healthcare. This position will partner with our data analytics, privacy and data security, and Manatt Digital groups.

Responsibilities:

Successful candidates will be innovative, out-of-the box thinkers with deep regulatory expertise and specific experience in the regulation of digital health products. Position will be responsible for providing clients with strategic and technical guidance to help them successfully navigate the FDA Center for Devices and Radiological Health's Digital Health and Digital Health Software Pre-Certification (Pre-Cert) programs. Ideal candidates will have demonstrated expertise in one or more of the following digital health focus areas: Pre-Cert Programs, Software as a Medical Device (SaMD), Medical Device Data Systems (MDDS), Mobile Medical Apps (MMA), clinical trials/studies, regulatory review and submission process for medical devices (including 501(k)s, PMAs, 513(g) requests, de novo petitions, and HUD, HDE and IDE applications). Experience guiding clients through the FDA approval process and demonstrated ability to successfully navigate the FDA's complex submission and review process are essential. Candidates will be able to apply extensive regulatory expertise to determine the best approach to help clients achieve successful results, including identifying potential issues and regulatory risks. Working knowledge of AI/machine learning, cybersecurity, health IT, wireless medical devices, telemedicine and medical device interoperability is a plus.

Qualifications:

  • Master's degree from a leading institution in a relevant area of study, or an equivalent combination of education and work experience.
  • Seven or more years of substantive regulatory experience, preferably as a subject matter expert in one or more of the digital health focus areas.
  • Demonstrated interest in and enthusiasm for digital health and healthcare issues and trends.
  • Strong client-facing skills with demonstrated experience in developing and managing client relationships.
  • Excellent written and verbal communication skills in a variety of settings and media.
  • Ability to develop training/presentation materials for key stakeholder audiences on significant changes/updates on digital health regulations, procedures and programs.
  • Self-starter with the ability to work independently as well as in collaboration with others in a fast-paced environment.

Join the Team:

All candidates must apply through our online application portal. Required application materials include a resume and cover letter.

EEO/AA Employer/Veterans/Disabled

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We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.
VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all of our locations
Please contact Holly Brown at 310-231-5409 or hbrown@manatt.com with any questions

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