International Regulatory Affairs Specialist (ADX-133-19)
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.
- 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
- 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
- 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