Regulatory Affairs Manager

Regulatory Affairs Manager Katalyst Healthcares & Life Sciences - 4.0 Dallas, TX Job Details Contract 5 hours ago Qualifications FDA submissions Bachelor's degree Relationship management Biomedical regulatory compliance Productivity software Cross-functional communication

Full Job Description Job Description:

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. Seeking expert advice and develops device regulatory product strategies and identifies data and information requirements as needed by the project. Key RA representative and leader on product development teams for assigned projects; 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. Provides regulatory guidance to product development teams regarding design, development, validation and risk management. 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. Within the Global RA team, analyzes legislation and guidance and shares updates to organization under limited supervision. Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in internal initiatives to Veracyte Global Regulatory Affairs. Develops and assists in implementing and maintaining regulatory processes in accordance with

IVDR, MDSAP

etc. 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 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.