Director – IVD Regulatory Consulting

🕒 May 27

🇺🇸 United States – Remote

💵 $162k - $243k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Responsible for applying extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions. • Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics • Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients • Review and direct the development of analytical and clinical protocols, technical reports and other company documents for use in regulatory submissions and in response to queries from regulatory agencies • Identify and collaborate with external thought-leaders and technical experts required to support research and development • Manage, motivate, and develop staff to ensure a scalable model within the Regulatory practice as a whole

🎯 Requirements

• Bachelor’s degree in Life Sciences or equivalent work experience • Minimum 5 years of applicable consulting experience with a focus in regulatory affairs • Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment • Strong written and verbal communication skills • Strong leadership, team building and interpersonal skills • Strong business and financial acumen • Strong scientific and analytical skills • Ability to think outside of the box and solve difficult problems with effective solutions • Direct experience working with small and large companies to design global regulatory and commercialization strategies • Experience managing staff members and project teams

🏖️ Benefits

• discretionary annual bonus • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation