Regulatory Affairs Manager
Yesterday
🇺🇸 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
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