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

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

Director – IVD Regulatory Consulting

Key skills