Director – IVD Regulatory Consulting

Precision Medicine Group

Director of Regulatory Consulting at Precision Medicine Group responsible for regulatory affairs and business solutions in pharma and life sciences. Oversight of submissions and strategic regulatory approaches for clients.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesLead💰 $162,000 - $243,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsquality systemsmarketing authorization processanalytical protocolsclinical protocolstechnical reportsregulatory submissionsglobal clearancepost-market requirementsbusiness solutions

Soft Skills

written communicationverbal communicationleadershipteam buildinginterpersonal skillsbusiness acumenfinancial acumenscientific skillsanalytical skillsproblem-solving

Certifications

Bachelor’s degree in Life Sciences