25 days old

FDA Drug and Device Attorneys

Hyman, Phelps & McNamara, P.C.
Washington , District of Columbia 20005
  • Job Type
    Law Firm Associate
  • Job Status
    Full Time

Hyman, Phelps & McNamara, P.C., the country's premier FDA law boutique, has two opportunities for attorneys to work with our drug development and device teams.

The ideal drug development candidate must possess at least two years of relevant experience working in the drug development arena, either by working at FDA or by assisting companies develop product development strategy or navigate the regulatory process.  We are flexible on years of legal experience.  Strong verbal and writing skills are required. 

The device attorney will assist medical device manufacturers with product development, FDA approval and clearance, and post-market compliance.  Qualified candidates should have familiarity with premarket strategies, including:

  • Investigation Device Exemption requirements
  • Premarket Notifications (510(k) clearances)
  • Premarket Approval Applications (PMAs)
  • De Novo Petitions
  • Pre-submissions
  • Product classification and reclassification

The ideal device candidate will have experience working at FDA or with a medical device company, and prior big law firm experience is helpful.

The boutique, collaborative nature of HPM allows attorneys to work closely with clients and in-house regulatory experts to bring exciting new technologies to market.  Compensation is competitive and commensurate with experience.  HP&M is an equal opportunity employer.   

Please send your curriculum vitae, transcript, and a writing sample to Anne K. Walsh (awalsh@hpm.com).  Candidates must be members of the DC Bar or eligible to waive in.

Requirements

Substantive drug development or device pre-submission experience  

Strong verbal and writing skills

Categories

Posted: 2020-10-02 Expires: 2020-11-01

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FDA Drug and Device Attorneys

Hyman, Phelps & McNamara, P.C.
Washington , District of Columbia 20005

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