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.


  • 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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Expert Pharma FDA Remediation & Quality


Posted 5 days ago

VIEW JOBS 2/20/2020 12:00:00 AM 2020-05-20T00:00 Qualifications * Advanced degree or or MBA * Minimum 5 years of experience within pharmaceutical quality assurance and regulatory compliance, working for the Food and Drug Administration (FDA)/Office of Regulatory Affairs (ORA) * Have knowledge of, and relationships with, investigators and leadership within District Offices * Know the immediate best steps in responding to a FDA 483 or Warning Letter * Knowledge of the pharmaceutical regulations (21CFR, Eudralex, etc.) * Certified Quality Auditor or Engineer (CQA, CQE) nice to have * Demonstrated aptitude for analytics * Ability to work collaboratively in a team environment * Ability to work effectively with people at all levels in an organization * Skills to communicate complex ideas effectively * Willingness to travel up to 80% Who You'll Work With At McKinsey, you can build a career out of making things happen! You'll be working with McKinsey's Quality, Compliance, & Remediation practice. Our Quality, Compliance, & Remediation practice assists our clients in solving the world's toughest problems. Blending strategic thinking with hands-on practicality, our teams of consultants and experts work to develop and implement operational strategies that solve our clients' most critical problems on a global scale. What You'll Do You will work in teams to collaborate as Experts, often working with multiple project teams across a dynamic set of situations in a way that leverages your deep knowledge in a specific area. You will make a meaningful, hands-on contribution by applying a broad range of creative problem-solving skills, combining deep technical and analytical excellence to help solve your piece of the overall client puzzle. In addition, you will work with senior leaders, identifying gaps and opportunities to apply frameworks that substantially improve performance in key areas. In this exciting collaborative culture, you will integrate with other teams at multiple points in a project, leading workshops to help build a change story or vision, often leading longer term engagements with teams, such as setting the agenda, synthesizing output and assisting in carrying out the study. In addition, you will likely develop short and long-term plans for all relevant levels of client leadership, with anticipated deliverables, outcomes, and required resources to sustain the transformation. Mckinsey Washington DC

FDA Regulatory Associate

Manatt, Phelps & Phillips, LLP