Director, IVD Regulatory Consulting
New
P
Precision for MedicineLife Sciences
Remote, United StatesFull-TimeDirector
Salary162,000 - 243,000 USD per year
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Job Details
- Experience
- Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment
- Required Skills
- Project ManagementBusiness DevelopmentCompliance
Requirements
- Bachelor’s degree in Life Sciences or equivalent work experience.
- Minimum 5 years of applicable consulting experience with a focus in regulatory affairs.
- Minimum 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.
- Direct experience working with small and large companies to design global regulatory and commercialization strategies.
- Experience managing staff members and project teams.
Responsibilities
- Direct the preparation of submissions and other documentation for global clearance/approval of in vitro diagnostics.
- Design strategic approaches to regulatory approvals, clearances, and post-market requirements.
- Review and direct the development of analytical and clinical protocols and technical reports.
- Identify and collaborate with external thought-leaders and technical experts.
- Generate new business through own network and support proposal development.
- Lead workshops and conference curriculums in translational and regulatory science.
- Advise on contracts, work orders, and change orders.
- Manage, motivate and develop staff within the regulatory practice.
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