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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.
POSITION SUMMARY:
The International Regulatory Affairs Specialist will be responsible for generating high quality regulatory submissions for IVD marketing outside the United States. The position will accomplish this by drafting technical files, informing project teams of international requirements, boosting Archer’s command of international standards, and promoting understanding of international resource utilization with Archer management.
RESPONSIBILITIES:
- 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.
QUALIFICATIONS:
- 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
EDUCATION:
- Minimum B.S./B.A, preferably in a technical field.
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