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Director, IVD Regulatory Consulting

17 minutes ago
United States
Full-time
Lead
Compliance Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 114

Description

  • Direct the preparation of global regulatory submissions, reports, and related documentation for in vitro diagnostics approvals and clearances.
  • Design regulatory strategies for approvals, clearances, and post-market requirements that align with client business objectives.
  • Review and guide analytical and clinical protocols, technical reports, and other documents for regulatory submissions and agency responses.
  • Collaborate with external thought leaders and technical experts to support research, regulatory authorization, and marketing efforts.
  • Review program planning materials, including project plans, communication plans, timelines, and approval requirement documents.
  • Apply quality systems expertise to help clients achieve market readiness in regulated environments.
  • Generate new business through personal professional networks.
  • Partner with business development and account management teams on proposals, bid defenses, work orders, change orders, and master service agreements.
  • Lead workshops and conference curriculums in translational and regulatory science for in vitro diagnostics.
  • Manage, motivate, and develop staff while ensuring quality and integrity of client work products and engagements.

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 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

  • Salary range of $162,000 to $243,000 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance coverage.
  • 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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