Associate Attorney

2 weeks ago


Washington, United States Marina Sirras & Associates LLC Full time

FDA Regulatory Associate


Our client, a top law firm in the area of FDA Law, is seeking a 2nd to 4th year associate to add to their strong and busy associate team. This position is based in the firm’s Washington DC office.


Overview:

This position will work on a team to assist clients with a wide variety of FDA regulatory topics across FDA-regulated products. Types of matters include:

  • Developing regulatory strategy for obtaining marketing authorization
  • Meeting with FDA on behalf of clients seeking marketing authorization and in other interactions with the Agency
  • Advising on and developing policies for regulatory compliance matters including complaint handling, field actions, recalls, and promotional review
  • Conducting internal investigations and audits
  • Responding to government inspections and other compliance matters
  • Conducting due diligence related to transactions and securities offerings


Qualifications:

  • 2-4 years of experience (seeking law school class years 2020-2022)
  • Experience working at FDA or prior big firm experience, including FDA regulatory law experience
  • Experience with medical device regulatory issues a plus
  • Strong verbal and writing skills are required
  • Must have a J.D. from an accredited law school and possess strong academic credentials
  • Must have Washington DC Bar admission, or eligibility to waive in


All candidates must be authorized to work in the U.S.


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