Precision for Medicine
Life Sciences
Director,IVDRegulatoryConsulting
“Director, IVD Regulatory Consulting at Precision for Medicine. Skills: Regulatory affairs, Consulting, Life sciences, In vitro diagnostics. Apply expertise in regulatory affairs. Manage quality systems”
What You'll Achieve.
Develop actionable business solutions; Achieve optimal business solutions for clients; Guide clients towards successful readiness to market products; Ensure scalable model within the Regulatory practice
Industry & Context.
Solve difficult problems with effective solutions
What They're Looking For.
Must Have
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, written and verbal communication skills, leadership, team building and interpersonal skills, business and financial acumen, 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
Nice to Have
Master's degree
What You'll Do.
Apply expertise in regulatory affairs
Manage quality systems
Prepare submissions for global clearance/approval
Design strategic approaches to regulatory approvals
Review analytical and clinical protocols
Identify and collaborate with external experts
Review program essential tools
Edit regulatory communication documents
Apply quality systems expertise
Generate new business
Develop customized program recommendations
Lead workshops and conference curriculums
Evaluate requests for proposals
Advise on work orders
Assist with client bid defense meetings
Be the regulatory compliance subject matter expert
Convert new business prospects
Identify client needs
Develop solutions for clients
Stay abreast of regulatory developments
Refine go to market strategy
Edit standardized start-up procedures
Ensure quality of client work products
motivate and develop staff
How You'll Work.
Team & Collaboration
Collaborate with external thought-leaders and technical experts; Work in conjunction with the management team; Work in partnership with the business development team; Collaborate with the business development account management team
Communication Scope
Written and verbal communication skills; Communicate key regulatory considerations
Process & Methodology
Manage project plans, Manage project teams
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