Director – IVD Regulatory Consulting

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for utilizing extensive expertise and deep knowledge of regulatory affairs, quality systems, and the marketing authorization process for both small and large pharmaceutical and life science companies to create actionable business solutions.

• Oversee the preparation of submissions and other necessary documentation for global clearance or approval of in vitro diagnostics.

• Develop strategic methodologies for regulatory approvals, clearances, and post-market requirements that align with optimal business solutions for clients.

• Evaluate and guide the creation of analytical and clinical protocols, technical reports, and other corporate documents intended for regulatory submissions and responses to inquiries from regulatory authorities.

• Identify and collaborate with external thought leaders and technical experts essential for supporting research and development.

• Lead, inspire, and develop staff to ensure a scalable model within the Regulatory practice as a whole.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or equivalent professional experience.

• At least 5 years of relevant consulting experience with an emphasis on regulatory affairs.

• Minimum of 7 years of experience in a medical device, pharmaceutical management, clinical trial, and/or pharmaceutical services consulting setting.

• Excellent written and verbal communication abilities.

• Strong leadership, team-building, and interpersonal skills.

• Solid business and financial insight.

• Proficient scientific and analytical capabilities.

• Capacity to think creatively and resolve challenging issues with effective solutions.

• Direct experience collaborating with both small and large companies to formulate global regulatory and commercialization strategies.

• Experience in managing staff and project teams.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.