Vice President of Regulatory, Clinical & Quality Affairs

Vice President of Regulatory, Clinical & Quality Affairs
East Coast

Required Experience:

Significant experience (10+ years) in regulatory affairs within the IVD

Significant experience (10+ years) in regulatory affairs within the IVD industry, including leadership roles.

Bachelor’s degree in a scientific or technical discipline (e.g., Biology,

Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biomedical Engineering, or related field); advanced degree preferred

A leading Global Diagnostics Company specializing in life science and clinical diagnostics solutions for infectious and gastroenterological diseases, our client has become a trusted partner for research and clinical laboratories, offering innovative molecular and immunodiagnostic products. Their commitment to high-quality, user-friendly, reliable, and accurate solutions is underpinned by a culture of respect, dedication, empowerment, and creativity.

The company has grown to become a prominent producer of novel immunodiagnostic reagents and a market leader in the molecular diagnostics field, specializing in infectious and genetic diseases. Their combined expertise allows them to offer technologically advanced real-time PCR kits and automated instrument platforms. The firm is seeking a Vice President Regulatory & Clinical Affairs ideally for East Coast.

The clinical diagnostics business is dedicated to the continuous development of an expanding test menu of assays that aid in the detection of infectious, genetics and gastroenterological diseases, as well as innovative molecular diagnostics tests and immunodiagnostic antibodies. The clinical diagnostics products portfolio includes instrumentation systems, software, and reagents that are sold into hospitals, reference labs and physician offices.

The Vice President of Regulatory & Clinical Affairs is responsible for developing and executing the global regulatory strategy. This includes all regulatory aspects of new product development, clinical trials, submission to regulatory agency and post market support and vigilance. Experience in direct negotiation with the FDA regarding the approval of diagnostic products generally and molecular products specifically are required.

Key Duties, Activities and Responsibilities:

• Develop and execute comprehensive global regulatory strategies to support product development, commercialization, and lifecycle management across the US, EU, and Canada.
• Lead and oversee all regulatory submissions to the FDA, including but not limited to 510(k), PMA, EUA, and De Novo applications.
• Act as the primary negotiator with the FDA, managing pre-submission meetings, addressing regulatory questions, and ensuring alignment with agency requirements.
• Ensure successful clearance and compliance with the European In Vitro Diagnostic Regulation (IVDR) for products marketed in the EU.
• Oversee regulatory strategies and submissions in Canada, ensuring compliance with Health Canada’s regulations.
• Collaborate with cross-functional teams, including R&D, Clinical, and Quality, to provide regulatory guidance during product development and post-market phases.
• Monitor and interpret evolving regulatory landscapes in the US, EU, and Canada, proactively addressing potential impacts on company products.
• Build and manage a high-performing regulatory affairs team to support global initiatives.

Relationship Management:

• Ability to explain impact of regulatory requirements on product development and gain buy in on regulatory strategy across the organization.
• Ability to navigate discussions with the FDA to attain positive outcomes and meet company objectives

Administrative Management:

• Manage…