FDA + Healthcare Regulatory and Compliance Associate (Mid-Level)

Morrison & Foerster, LLPWashington, DC
Onsite

About The Position

MoFo is a destination law firm for talented, ambitious attorneys who value collaboration, teamwork, and commitment to excellence. We are known around the world not only for delivering innovative yet practical client service but also for serving as an incubator for our top-notch talent. MoFo consistently receives top-tier rankings from leading directories and publications, speaking to our legal capabilities, dedication to creating an inclusive workplace, and commitment to our communities. Our FDA + Healthcare Regulatory and Compliance Practice Group advises clients in the life sciences and healthcare industries, helping them navigate complex regulatory, compliance, healthcare system, and marketplace issues. With a strategic and comprehensive life-cycle approach, we counsel domestic and international clients, from pre-product launch to post-market representation in the medical device, pharmaceutical, food and dietary supplement, biotechnology, healthcare technology, and cosmetic industries, ensuring that our clients are U.S. FDA-compliant and optimally positioned for maximum coverage and reimbursement, entry into new global markets, and further research and development.

Requirements

  • 3–5 years of experience in a leading law firm’s FDA practice and/or at FDA or USDA.
  • Experience advising on FDA- and USDA-regulated product areas, including experience representing food, drug, supplement, cosmetic and/or device clients.
  • Admitted to the state bar in which you are practicing or eligible to waive in.

Nice To Haves

  • Experience with food regulatory matters is strongly preferred.
  • Experience with, or a strong interest in, counseling fast-moving brands and retailers in the food, beverage, and dietary supplement space.

Responsibilities

  • Advising clients in the life sciences and healthcare industries on complex regulatory, compliance, healthcare system, and marketplace issues.
  • Counseling domestic and international clients on a strategic and comprehensive life-cycle approach, from pre-product launch to post-market representation.
  • Ensuring clients in the medical device, pharmaceutical, food and dietary supplement, biotechnology, healthcare technology, and cosmetic industries are U.S. FDA-compliant.
  • Positioning clients for maximum coverage and reimbursement, entry into new global markets, and further research and development.
  • Counseling fast-moving brands and retailers in the food, beverage, and dietary supplement space.
  • Delivering sophisticated, clear, and actionable advice across the product lifecycle, including product development strategy, labeling, advertising and promotion, safety and compliance, adverse event reporting, recalls, agency inspections, and remediation of inspection findings.
  • Taking ownership of matters and working directly with clients.
  • Operating with a high degree of independence.
  • Working effectively across practice groups and contributing to a collaborative team environment.

Benefits

  • A variety of options for medical, dental, vision, life, and disability coverage to meet the needs of you and your family.
  • Industry-leading parental leave and family benefits including adoption and fertility treatment options, backup child and elder care, and more.
  • Tax free health accounts: HSA and FSA.
  • 401(k) or Roth 401(k) plans.
  • Global wellness program, including free access to health care advocates, Employee Assistance Program, Talkspace, and Calm apps.
  • Flex Time Away and reduced schedule arrangements.
  • Paid annual fees for primary state bar registration, and up to two professional associations.
  • Dedicated in-house pro bono counsel to assist with identifying pro bono organizations and matters to work with.
  • Matching gift programs for law school and charitable organization donations.
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