Director, IVD Regulatory Consulting
New
United StatesFull-TimeDirector
Salary162,000 - 243,000 USD per year
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Job Details
- Experience
- 7+ years of industry experience; at least 5+ years of direct regulatory affairs consulting experience
- Required Skills
- Project ManagementBusiness DevelopmentStakeholder management
Requirements
- Bachelor’s degree in Life Sciences or related field (Master’s preferred).
- 7+ years of industry experience in medical devices, pharmaceuticals, clinical trials, or regulatory consulting.
- At least 5+ years of direct regulatory affairs consulting experience, ideally focused on diagnostics or IVDs.
- Strong understanding of global regulatory frameworks, quality systems, and marketing authorization processes.
- Demonstrated ability to develop and execute global regulatory strategies for complex products.
- Strong leadership, communication, and stakeholder management skills.
- Business acumen with the ability to support client development and commercial growth initiatives.
- Analytical mindset with strong problem-solving skills and the ability to navigate complex regulatory challenges.
- Experience managing teams and cross-functional project delivery.
Responsibilities
- Lead the development and execution of global regulatory strategies for IVD products, including submissions, approvals, and post-market requirements.
- Direct preparation, review, and submission of regulatory documentation and technical reports, ensuring alignment with global regulatory standards.
- Provide strategic guidance on analytical and clinical study design to support regulatory filings and agency responses.
- Collaborate with internal teams, external experts, and scientific leaders to strengthen regulatory and development strategies.
- Support business development activities including proposal development, bid defense presentations, and client advisory discussions.
- Translate client needs into actionable regulatory strategies and support go-to-market planning and commercialization efforts.
- Oversee internal quality, documentation standards, and project governance for consulting engagements.
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