Director, IVD Regulatory Consulting

🕒 May 27

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

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.

📋 Description

• 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 • Identify and collaborate with external thought-leaders and technical experts required to support research and development • Review and edit regulatory communication, submission, timeline and approval requirement documents • Apply quality systems expertise to guide clients towards successful readiness to market products • Generate new business through your own network • Work in conjunction with management to design and develop customized program recommendations • Lead workshops and conference curriculums in regulatory science for in vitro diagnostics • Advise on work orders, change orders, master service agreements and other documents • Collaborate with business development account management team

🎯 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

• Annual discretionary bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation