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

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