Regulatory Affairs Manager
October 31
🇺🇸 United States – Remote
💵 $95k - $133k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🗽 H1B Visa Sponsor
Description
• Responsible for regulatory affairs and marketing authorization process • Lead preparation of submissions for global clearance/approval of clinical trial assays and IVD-CDx products • Serve as regulatory lead on CDx program development teams • Represent Precision in correspondence with regulatory agencies • Design strategic approaches to regulatory approvals • Review development of protocols, technical reports, and other documents • Stay abreast of regulatory developments and communicate impacts • Perform regulatory impact assessments for changes to products • Support post-market surveillance program
Requirements
• BS Degree in Sciences or equivalent in a Scientific or similar discipline • Minimum of 5+ years of regulatory experience in medical device industry • Knowledge of global IVD regulations including US, EU, UK, APAC, and MENA
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
Apply NowSimilar Jobs
October 28
Amgen
10,000+
Manage end-to-end labeling processes for Amgen’s pre- and post-marketed products.
🇺🇸 United States – Remote
💵 $111.9k - $133.4k / year
💰 Post-IPO Debt on 2022-12
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🗽 H1B Visa Sponsor
October 26
Harbor.ai
2 - 10
Harbor seeks a Compliance Analyst for their Vendor Governance Solutions team.
October 26
Midi Health
51 - 200
Compliance Manager for telehealth firm ensuring regulatory conformity and training.
