Associate Director - IVD Regulatory Consulting

February 26

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Precision For Medicine

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Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

Global Clinical Trial Services • Specialty Lab Services • Translational Science • Clinical Data Management • Biostatistics

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

📋 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 of the job include consulting services, business development, and administrative tasks. • Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics, including Precision’s own CDx products. • Serve as a regulatory lead on Precision CDx program development project teams. • Stay abreast of latest regulatory developments and communicate to the project teams for impact and possible implementation within Precision’s CDx programs.

🎯 Requirements

• Minimum Required: • 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 • Other Required: • 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

• This role is also eligible for a discretionary annual bonus • health insurance • retirement savings benefits • life insurance and disability benefits • parental leave • paid time off for sick leave and vacation, among other benefits.