Regulatory Affairs Manager

Responsibilities

• Provides global regulatory expertise and strategic leadership to IVD product development teams.
• Negotiates with and influences team members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or national regulations.
• Manages the preparation of technical documents for review by regulatory bodies, and revises these to enable effective presentation of data and strategy to regulatory agencies.
• Supports third party on-site audits and inspections.
• Stays abreast of regulatory procedures and changes in regulatory climate.
• Develops, implements and documents policies and procedures within the regulatory affairs department.
• Participates in internal initiatives to Veracyte Global Regulatory Affairs.
• Represents RA on project initiatives with other groups to drive efficiencies across the company.

Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related life sciences.
• 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred: 7+ years of pre-market regulatory experience in IVD industry).
• Demonstrated hands-on experience in preparing regulatory clearance/approvals for IVD products in the EU, USA, OUS; (Preferred: working experience with IVD submissions under IVDR Regulations is highly desirable).
• Solid working knowledge of global regulatory requirements related to in-vitro diagnostics systems, laboratory automation and software / hardware components of IVD medical devices.
• Strong communication skills, both oral and written.
• Effective organizational and planning skills to apply daily in a multidisciplinary environment.
• Proficient in Microsoft Office Suite.