Senior Regulatory Specialist

• Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instrumentation and software/hardware, and experience in assay development.
• Demonstrated ability to interface with subject matter experts (SME) and regulatory agencies.
• Demonstrated ability to articulate regulatory risks, potential regulatory challenges, and optimal regulatory strategies.
• Prepare, compile, and publish electronic pre-market and post-market regulatory submissions in approved geographical scope. Compile IVDR compliant Technical Documentation for IVD medical devices to support EU CE-Mark.
• Interact with business partners to support ROW submissions for IVD medical devices (Asia Client, EMEA, LATAM, Canada etc.). Prepare and maintain international submission dossiers.
• Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on a regular basis.
• Review of product labeling, materials for publication, literature and Web site for accuracy, consistency and regulatory compliance.
• Develop and/or revise regulatory procedures.
• Provide regulatory support to existing and new cross-functional product core teams.
• Review new product design protocols related to verification and validation, risk assessment, etc.
• Mentor and instruct junior staff members on how to complete key regulatory activities such as submissions.
• Supervise and take responsibility for the quality of work completed by junior staff on shared projects.
• Support on-market regulatory activities as assigned by management.
• Assess and communicate new and/or updated regulations to technical functions within the company.

Requirements

• B.S degree with 5-8+ years of experience in Regulatory Affairs within the IVD or medical device industries OR master's degree in biomedical engineering and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within the IVD or medical device industries.
• Software/instrumentation experience strongly preferred.
• Point of care molecular IVD test system experience preferred, with knowledge of instrumentation and assays.