Regulatory Affairs Director - IVD & Diagnostics

Element Biosciences Inc; San Diego (CA); On-site; USD 152,000 - 215,000; Full time

Benefits offered by this job

Stock options

Discretionary annual bonus

No cost health insurance plans

401k with company match

Flexible paid time off

Job summary

Element Biosciences is seeking a Director of Regulatory Affairs to build and lead the regulatory function across IVD, NGS, software, and regulated life science instrumentation. The role drives regulatory strategy from development through lifecycle management and collaborates with C-suite, Product, R&D, Quality, and Legal to balance regulatory risks with business speed.

The role is onsite in San Diego, with responsibility for US, EU, and other markets, and requires deep IVD/regulatory expertise,

Qualifications

• 12+ years in medical device or IVD Regulatory Affairs with market authorization experience
• Experience with FDA and EU IVDR; cross‑jurisdictional programs
• Ability to advise senior executives and influence decisions without positional authority
• Experience building or scaling a Regulatory Affairs function
• Deep knowledge of ISO 13485, ISO 14971, and post‑market requirements

Responsibilities

• Own and lead global regulatory strategy for IVD, NGS, software, and regulated life science instruments
• Serve as senior Regulatory Affairs advisor to executive leadership and cross-functional teams
• Establish regulatory strategies early in product development, including RUO-to-diagnostic considerations
• Lead regulatory strategy and execution for US, EU, and other priority markets
• Lead interactions with regulatory authorities, notified bodies, and external stakeholders
• Build and scale the Regulatory Affairs function, governance, processes, and infrastructure

Skills

Regulatory strategy leadership

Cross-functional collaboration

Regulatory judgment

Stakeholder management

Regulatory affairs expertise

Education

Bachelor's degree in life sciences/engineering/regulatory affairs

Advanced degree or RAC preferred

Job description

Element Biosciences is seeking a Director of Regulatory Affairs to build and lead the regulatory function across IVD, NGS, software, and regulated life science instrumentation. The role drives regulatory strategy from development through lifecycle management and collaborates with C-suite, Product, R&D, Quality, and Legal to balance regulatory risks with business speed.

The role is onsite in San Diego, with responsibility for US, EU, and other markets, and requires deep IVD/regulatory expertise,