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Regulatory Affairs Manager (JP7687)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Manager (JP7687)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 3 months with likely extensions
Job posting date: 17 September 2020
Note: Remote until COVID-19 restrictions are lifted.
 
3 Key Consulting is hiring a Regulatory Affairs Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Candidate will be working remotely then required to be on site once it opens.
  • 5+ years of Regulatory Device - IVD/CDx regulations.
  • Must have experience within JAPAC region especially in China, Japan, South Korea, Taiwan, Australia.
  • Bachelor’s degree - any study

    Job Details:
  • Develop, implement, communicate, and maintain global regulatory strategies and plans.
  • Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission.
  • Review and approve device design control deliverables, as applicable per internal policies and procedures.
  • Review standards and guidance for applicability; assist in establishing cleint's regulatory positions and communicating these to relevant stakeholders.
  • Perform change management assessments; determine and communicate post-approval reporting requirements.
  • Develop and support implementation and maintenance of regulatory processes.
  • Lead and perform internal policy reviews for global regulatory guidance and regulations.
  • Contribute to and participate in internal and external education and training activities.
  • Identify and communicate relevant guidance, policies, standards, and regulations.
  • Build and maintain effective relationships with internal and external stakeholders.
 
Top Must have Skill Sets:
  • Have good working knowledge and understanding of device/IVD/CDx regulations and guidance in JAPAC region especially in China, Japan, South Korea, Taiwan, Australia.
  • Be able to develop and maintain regulatory strategy and plan.
  • Be able to organize effective communication within a large cross-functional team.
 
Day-To-Day Responsibilities:
Responsible to all regulatory aspects of device/IVD/CDx of products including strategy and plan development and update, team meetings, briefing book development, regulation and guidance readout, consultant management.
 
Employee Value Proposition:
IVD/CDx is upcoming new field in US & JAPAC region. Huge exposure to new regulatory framework challenges in the Asia/Pacific region.
 
Red Flags:
  • No experience in JAPAC regulations.
  • No experience in Medical device/IVD/CDx regulation
 
Interview Process:
2 phone interviews, one pre-screen and one with multiple interviewers.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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