Director, IVD Regulatory Consulting
New
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Precision Medicine GroupLife Sciences
Remote, United StatesFull-TimeDirector
Salary162,000 - 243,000 USD per year
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Job Details
- 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
- Required Skills
- Business Development
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 of 7 years of experience in medical device, pharmaceutical management, or clinical trials
- Strong written and verbal communication skills
- Strong leadership, team building and interpersonal skills
- Strong business and financial acumen
- Strong scientific and analytical skills
- Experience managing staff members and project teams
- Experience designing global regulatory and commercialization strategies
Responsibilities
- 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
- 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 your own network
- Lead workshops and conference curriculums in translational and regulatory science
- Provide regulatory compliance subject matter expertise during client bid defense meetings
- Manage, motivate, and develop staff within the Regulatory practice
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