Regulatory Affairs Manager

We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development activities with a key focus on in vitro diagnostic systems including assay, software and hardware. This role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of processes for the regulatory affairs department that comply with internal, domestic, and international quality regulations.

Responsibilities

• The Regulatory Affairs Manager will report to the Senior Director of Global Regulatory Affairs (located in the EU) and will be a key member of the global RA department.
• Seek expert advice and develop device regulatory product strategies and identify data and information requirements as needed by the project.
• Serve as key RA representative and leader on product development teams for assigned projects; negotiate with and influence team members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or national regulations.
• Provide regulatory guidance to product development teams regarding design, development, validation and risk management.
• Manage the preparation of technical documents for review by regulatory bodies, and revise these to enable effective presentation of data and strategy to regulatory agencies.
• Support third party on-site audits and inspections.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Within the Global RA team, analyze legislation and guidance and share updates to the organization under limited supervision.
• Develop, implement and document policies and procedures within the regulatory affairs department under supervision of manager.
• Participate in internal initiatives to Veracyte Global Regulatory Affairs.
• Develop and assist in implementing and maintaining regulatory processes in accordance with IVDR, MDSAP etc.
• Represent 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 experience: 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 experience: 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.
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts on complex projects.
• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment.
• Able to work with minimal supervision in a fast-paced environment
• Proficient in Microsoft Office Suite.