Regulatory Affairs Specialist/Senior Specialist

Regulatory Affairs Specialist/Senior Specialist

Hybrid, San Diego

We're currently supporting A global healthcare diagnostics organization focused on developing and delivering innovative diagnostic solutions that support disease detection, patient monitoring, and clinical decision-making. The business operates within a highly regulated environment, with a strong focus on quality systems, regulatory compliance, product development, and advancing next-generation diagnostic technologies.

They're currently seeking a Regulatory Affairs Specialist/Senior Specialist who will be responsible for preparing and filing complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies. Ideally someone with experience in the diagnostics or biotech indsutry.

Key Responsibilities:

• Lead preparation, submission, and lifecycle management of global regulatory submissions (FDA, EU Notified Bodies, and other international authorities) for IVD products.
• Develop regulatory strategies for new product development, product changes, and post-market activities, providing guidance to cross-functional teams throughout the product lifecycle.
• Manage health authority interactions, submission timelines, agency correspondence, commitments, and responses while ensuring compliance with applicable regulations and guidance.
• Partner with R&D, Quality, Clinical, Engineering, and other SMEs to compile technical documentation, review scientific data, and ensure regulatory requirements are addressed.
• Assess regulatory impact of product changes, support change control activities, inspections, audits, and risk mitigation initiatives.
• Provide regulatory expertise on quality system documentation, technical reports, validations, and submission content.
• Drive projects independently, communicate status updates to leadership, identify process improvements, and support continuous improvement initiatives.
• Mentor junior regulatory team members and provide guidance on regulatory processes and best practices.

Required Skills & Experience:

• 4+ years within a regulated medical device, IVD, pharmaceutical, or biologics environment
• Strong knowledge of IVD regulations, reagent chemistry, laboratory automation, and software-enabled diagnostic platforms.
• Experience managing complex regulatory submissions and communicating with FDA, EU authorities, and international regulatory agencies.
• Ability to interpret technical/scientific data and translate complex information into clear regulatory documentation.
• Strong project management, analytical, problem-solving, and stakeholder management skills.
• Excellent written and verbal communication skills with the ability to influence cross-functional teams.
• Experience with regulatory documentation systems, change control processes, and tools such as SAP, JIRA, and document management platforms.
• Bachelor’s degree in Life Sciences, Engineering, or related scientific discipline required.

Apply today to learn more or reach out directly to rbanton@barringtonjames.com