International Regulatory Affairs Specialist (ADX-56-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Assist with the development and implementation of regulatory procedures, particularly focused on proper documentation for medical device registration outside the USA.
- Create draft planning documents to guide project teams on regulatory documentation requirements for a given region or country.
- Manage Archer’s international standards compliance program by monitoring changes, advocating with standards organization and coordinating internal gap assessments for compliance.
- Ensure Archer’s compliance to post-market requirements, such as complaint reporting, in regions where Archer sells regulated IVD products.
- Provide or arrange for training and informational materials to help Archer project teams with successful foreign registration.
- Assist in the hosting of audits by regulatory authorities.
- Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
- Four or more years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration outside the USA, experience in Asia-Pacific preferred.
- High degree of proficiency with MS Office and Adobe PDF creation
- Preference for candidates with language skills beyond English
- Familiarity medical device and/or IVD design control processes
- Experience with good manufacturing practice and good document practice.
- Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
- Fine research skills with a knack for sketching out solutions to novel issues.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work independently, and report progress efficiently.
- Ability to multitask and work within a fast-paced dynamic team environment
- Minimum B.S./B.A, preferably in a technical field.