FDA Regulatory Associate

Manatt, Phelps & Phillips, LLP Washington , DC 20319

Posted 2 months ago

The Washington, D.C. office of Manatt, Phelps & Phillips, LLP is seeking a highly qualified associate with two to five years of experience to join our nationally recognized healthcare regulatory practice to work on medical device regulatory matters.

Ideal candidates will have experience researching FDA medical device regulatory issues; providing advice on regulatory pathways; drafting regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); preparing responses to FDA premarket review; and posting market compliance questions and deficiencies. Scientific, health or biotech background is preferred. Experience at FDA is a plus.

Requirements:

  • Two to five years of experience or demonstrated interest in handling FDA medical device matters (scientific, health or biotech background preferred).

  • Stellar academic credentials and excellent writing, research and analytical skills.

  • A self-starter, highly motivated, intellectually curious, with the ability to work independently as well as in collaboration with others in a fast-paced environment.

  • D.C. Bar membership in good standing.

About Manatt Health:

Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand 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.

Join the Team:

All candidates must apply through our online application portal: https://www.manatt.com/careers. Required application materials include a cover letter, transcripts and writing sample (Two to three pages from your academic or work experience where you are the sole author).

EEO/AA Employer/Veterans/Disabled

Apply Now


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FDA Regulatory Associate

Manatt, Phelps & Phillips, LLP