Director, International Regulatory Affairs (ADX-180-20)
p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'}p.p2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'; min-height: 14.0px}
Director - International Regulatory Affairs
COMPANY SUMMARY:
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.
POSITION SUMMARY:
The Director, International Regulatory Affairs will be responsible for managing relationships with foreign regulatory agents and seeing international submissions for genomic devices and IVDs including companion diagnostics to a successful conclusion. For globally marketed products, this position will oversee ongoing product maintenance and evaluation of vigilance reporting.
RESPONSIBILITIES:
- Lead the development and implementation of regulatory procedures, particularly focused on proper documentation for medical device registration outside the USA
- Champion and collaborate on global regulatory product strategy with other members of Archer leadership
- 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
EXPERIENCE:
- BS/BA, preferably in a technical field
- 10+ years of experience in generating submissions, technical files, or other documentation in support of medical device/IVD registration outside the USA
- 5+ years building and supervising a successful regulatory team
- Familiarity medical device and/or IVD design control processes
- 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
- Experience with good manufacturing practice (cGMP) 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