POSITION SUMMARY:

The Sr. Manager, International Regulatory Affairs and Vigilance Reporting 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 complaint and vigilance reporting to health authorities around the world, including the USA.

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.
• 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: 

• 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

EDUCATION: