: Regulatory Affairs Manager (JP7687)
Thousand Oaks, CA
: 3 months with likely extensions
Job posting date
: 17 September 2020
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.
Top Must have Skill Sets:
- 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
- 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.
- 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.
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.
- No experience in JAPAC regulations.
- No experience in Medical device/IVD/CDx regulation
2 phone interviews, one pre-screen and one with multiple interviewers.
We invite qualified candidates to send your resume to email@example.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.