Manatt Health is seeking a highly qualified consultant or manager with relevant expertise to work on medical device regulatory matters. This is an exciting opportunity to be part of a nationally recognized healthcare strategy consulting team and work with clients who are passionate about improving healthcare.
Ideal candidates will have a deep understanding of the U.S. Food and Drug Administration's (FDA's) medical device regulatory issues as well as demonstrated ability to successfully navigate the FDA's complex submission and review process, and experience guiding clients through the FDA approval process. Experience with FDA policies and requirements, product development and submissions processes, regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); FDA premarket review responses, FDA jurisdictional and postmarket compliance issues, advertising and promotion compliance, and clinical trial guidance is preferred. 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.
- Master's degree from a leading institution in a relevant area of study, or an equivalent combination of education and work experience (scientific, health or biotech background preferred).
- Two or more years of regulatory experience, preferably in handling FDA medical device matters.
- Demonstrated interest in and enthusiasm for healthcare regulatory issues and trends.
- Stellar academic credentials and excellent writing, research and analytical skills.
- 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 on key changes/updates on regulations, procedures, and programs to key stakeholder audiences.
- 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.
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.
Join the Team:
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).