Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
Regulatory Affairs Manager
October 31
🇺🇸 United States – Remote
💵 $95k - $133k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
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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