Regulatory Affairs Director, Dx/CDx, Medical Devices
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $171,300 - $231,300 per year
Job Level
Lead
About the role
- Develop US regulatory strategy for designated program(s)
- Act as the representative of the US regulatory team at the global regulatory team (GRT)
- Drive the strategy and provide direction for Dx/CDx and Device related content of regulatory documents
- Provide submission gap analyses and identify potential risks
- Oversee communications, submissions, and approvals with regulatory agencies
- Maintain up-to-date knowledge of laws, regulations, and guidelines applicable to the US testing space
- Represent BeOne’s US Dx/CDx and MedDev regulatory function at industry consortium
Requirements
- Minimum BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry
- 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge
- Substantial working experience in medical devices/diagnostic development regulations
- Experience working with various Health Authorities, primarily FDA
- Sound understanding of the drug and diagnostic development process
- Recent experience with diagnostic testing to support clinical trials in all phases of study
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentsubmission gap analysisrisk identificationregulatory document preparationclinical trial supportdiagnostic testingmedical device regulationsdiagnostic development regulationsFDA regulationsdrug development process
Soft skills
communicationleadershipstrategic directioncollaborationproblem-solvingorganizational skillsinterpersonal skillsrepresentationadaptabilitycritical thinking
Certifications
BSMSPhDMDPharmD