Senior Manager, Regulatory Affairs

  • location: Germantown, MD
  • type: Permanent
  • salary: $110,000 - $115,000 per year
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job description

Senior Manager, Regulatory Affairs

job summary:
Seeking an experienced Regulatory Affairs professional, with experience specific to IVD products.

 
location: Germantown, Maryland
job type: Permanent
salary: $110,000 - 115,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Manage IVD product strategies and activities for submission, registrations and maintenance, globally.
  • Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development and other functions as required.
  • Leads communications and meetings with Regulatory Authorities on behalf of Regulatory Affairs leadership.
  • Support other company functions in customer facing issues involving Regulatory Affairs aspects.
 
qualifications:
  • Minimum Bachelor's Degree.
  • At least 5 years of relevant professional experience required.
  • Extensive knowledge of requirements and processes for US regulatory approval of in vitro diagnostic medical devices (ex-US knowledge is a plus).
  • Should be knowledgeable in companion diagnostics.
  • Good skills in standard PC software.
  • Good language skills in English.
  • Good verbal/written communication skills, especially for teleconferences.
  • Limited travel expected.
 
skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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