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Director, IVD Regulatory Consulting

3 weeks, 5 days ago
United States
Full-time
Lead
Business Development
Sales and Business Development
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 106

Description

  • Direct the preparation of global regulatory submissions and supporting documentation for in vitro diagnostics.
  • Design strategic approaches for regulatory approvals, clearances, and post-market requirements.
  • Review and guide analytical and clinical protocols, technical reports, and other submission documents.
  • Respond to regulatory agency questions and support negotiation with regulatory officials as needed.
  • Identify and collaborate with external thought leaders and technical experts to support R&D, authorization, and marketing.
  • Prepare and review project plans, communication plans, timelines, and other program management tools.
  • Review and edit regulatory communications, submission materials, and approval requirement documents.
  • Apply quality systems expertise to support client readiness to market products in regulated environments.
  • Generate new business through your professional network and support business development efforts.
  • Lead workshops, conference curriculums, and client bid defense meetings related to translational and regulatory science.
  • Manage, motivate, and develop staff to support a scalable regulatory practice.

Requirements

  • Bachelor’s degree in Life Sciences or equivalent work experience.
  • Minimum 5 years of applicable consulting experience with a focus on regulatory affairs.
  • Minimum 7 years of experience 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.
  • Ability to think creatively 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.
  • Master’s degree preferred.

Benefits

  • $162,000 to $243,000 USD salary range.
  • Eligible for a discretionary annual bonus.
  • Health insurance benefits.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.

Interested in this position?

Apply directly on the company website

Apply Now

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