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
- 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.
- 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.