Director, IVD Regulatory Consulting

Position Summary:The Director, Regulatory Consultant will be 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.Essential functions of the job include but are not limited to:Consulting ServicesDirect the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics, including the preparation of reports and negotiations with regulatory officials as requiredDesign strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clientsReview 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, regulatory authorization, and marketingResponsible for reviewing and providing information for program essential tools such as project plans, communication plans, etc.Review and edit regulatory communication, submission, timeline and approval requirement documents for assigned programs and other initiativesApply quality systems expertise to guide clients towards successful readiness to market products in a regulated environmentBusiness DevelopmentGenerate new business through your own networkWork in conjunction with the management team within the organization to design and develop customized, program recommendations and preliminary strategies for inclusion in client proposalsLead workshops and conference curriculums in the areas of translational and regulatory science for in vitro diagnosticsWork in partnership with the business development team to support the evaluation of requests for proposals and consider regulatory strategies that can be leveraged and regulatory approval timelinesAdvise on work orders, change orders, master service agreements and other contract related documentsAssist the business development team with client bid defense meetings by clearly and succinctly communicating the key regulatory considerations of the program to the project team and assisting with the development of the presentation materials for these meetingsBe the regulatory compliance subject matter expert who can speak to the strategic positioning and considerations of the program within the healthcare marketplace and who can discuss the established precedents from other similar programsCollaborate with the business development account management team to convert new business prospects into awarded and contracted business by participating in general capabilities presentationsProactively identify client needs and develop solutions by gaining an understanding of the client’s product, the brand objectives and other relevant industry trendsStay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of business by identifying market trends, paradigm shifts, etc.Support the development and refinement of the “go to market” strategyAdministrativeReview and edit standardized start-up procedures for new programs and consulting engagements by creating regulatory check-lists, customized hot sheet, etc.Ensure quality and integrity of all client work products and engagements, consistent with corporate standards.Manage, motivate and develop staff to ensure a scalable model within the Regulatory practice as a wholeSupport and contribute to Precision for Medicine cultureQualifications:Minimum Required:Bachelor’s degree in Life Sciences or equivalent work experienceMinimum 5 years of applicable consulting experience with a focus in regulatory affairsOther Required:Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environmentStrong written and verbal communication skillsStrong leadership, team building and interpersonal skillsStrong business and financial acumenStrong scientific and analytical skillsAbility to think outside of the box and solve difficult problems with effective solutionsDirect experience working with small and large companies to design global regulatory and commercialization strategiesExperience managing staff members and project teamsPreferred:Master’s degreePrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic d