International Regulatory Affairs Specialist (ADX-133-19)
COMPANY OVERVIEW:
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
POSITION SUMMARY:
Create and execute international product registration submissions to global health authorities. Represent international regulatory requirements in quality system strategy activities and project core teams. Support international distributors and authorized representatives to establish and maintain market access. Understanding of harmonized medical device standards and country specific requirements. Requires excellent technical writing skills and working knowledge of applicable scientific concepts.
RESPONSIBILITIES:
- Develop and execute international regulatory strategies to meet market access objectives
- Prepare and submit summary technical documents and international product approval submission packages, applications, updates and renewals
- Represent international market implications in development and sustaining core teams
- Review clinical, laboratory and bench study verification/validation documents to assure compliance with international regulatory submission requirements
- Review technical documents and labeling in support of international regulatory submissions
- Support regulatory impact assessment of design activities throughout design life-cycle, including design changes
- Support the regulatory intelligence function by representing international guidelines and standards. Provide impact assessment and recommend course corrections relevant to business objectives
- Identify and monitor domestic and global/country regulatory and product registration requirements
- Assist with regulatory assessment of international product complaints and global health authority inquiries
- Support health authority and notified body inspections
- Assist with Corrective and Preventive Actions, Nonconformance investigations, complaints and adverse reaction/event investigations or other failure investigations.
- Support global distribution partners and authorized representatives
QUALIFICATIONS:
- Strong preference for candidates with international regulatory submissions experience of IVD/CDx medical devices including CE marking, PMDA/MHLW, CFDA, KFDA and Health Canada
- Experience in med device industry regulated by cGMP, GDP, 13485, 14971 & Design Control
- Foreign language skills a plus
EDUCATION:
- Bachelor of Science degree (B.S.) in a health or life sciences discipline from a four-year college or university, and 4+ years of relevant regulatory affairs experience