Associate Director - IVD Regulatory Consulting

February 26

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Precision Medicine Group

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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.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• The Associate Director, Regulatory Consultant will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and diagnostics companies to develop business solutions for clients and colleagues within Precision for Medicine (Precision). • This position will also serve as regulatory liaison with regulatory agencies and pharma partners for Precision diagnostic products (e.g., companion diagnostics [CDx]). • Essential functions include directing the preparation of submissions and other documentation required for global clearance/approval of in vitro diagnostics, serving as a regulatory lead on Precision CDx program development project teams, and designing strategic approaches to regulatory approvals.

🎯 Requirements

• Bachelor's degree in Life Sciences or equivalent work experience • Minimum 2+ years of applicable consulting experience with a focus in regulatory affairs • Minimum of 5+ years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment, or an in vitro diagnostics environment, preferably with CDx • 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 • Ability to read, write, speak fluently, and comprehend the English language • Preferred: Master’s degree • Class III IVD, preferably CDx experience • FDA PMA and IVDR experience

🏖️ Benefits

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