Sr. Manager - International Regulatory Affairs (ADX-43-21) at ArcherDX
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
- 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.
- Identify and manage external partners such as authorized representatives, in-country agents, translation services, CROs and regulatory consultants.
- 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.
- Represent Archer at regulatory meetings in-person abroad and remotely, and interact with pharmaceutical and foreign regulatory partners as needed.
- Assist in the hosting of audits by regulatory authorities.
- Develop and manage an international regulatory affairs team along with a high functioning post-market vigilance team which partners with other cross-functional representatives.
- Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
- Six or more years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration outside the USA.
- Three or more years building and supervising a successful regulatory team.
- Strong regulatory strategic thinker with the skills to present resourcing, timeline and tradeoff scenarios to company leadership regarding global deployment of regulated products.
- 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.