Global Regulatory Strategy Leader – IVD/NGS & Diagnostics

Element Biosciences; 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 its regulatory function for IVD, NGS, software, and life science instrumentation. This onsite San Diego role reports to the Chief Supply Chain Officer and partners with executive leadership to balance regulatory risk and speed to market.

The successful candidate will possess deep IVD/medical device regulatory expertise, demonstrate cross-functional leadership, and guide strategy across multiple jurisdictions,

Qualifications

• Minimum 12+ years in medical device or IVD Regulatory Affairs with product development and lifecycle management.
• Experience building/regrowing regulatory functions and teams.
• Deep knowledge of ISO 13485, ISO 14971, post-market requirements, and labeling.

Responsibilities

• Own and lead global regulatory strategy for IVD, NGS, software, and regulated life science products throughout development and lifecycle.
• Advise executive leadership on regulatory pathways, risks, and business implications.
• Lead regulatory strategy for US, EU, and priority international markets.
• Manage interactions with regulatory authorities, notified bodies, and external stakeholders.
• Build and scale the Regulatory Affairs function, governance, processes, and infrastructure.

Skills

Regulatory strategy

Cross-functional leadership

FDA/IVD knowledge

Regulatory judgment

Risk assessment

Education

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

Job description

Element Biosciences is seeking a Director of Regulatory Affairs to build and lead its regulatory function for IVD, NGS, software, and life science instrumentation. This onsite San Diego role reports to the Chief Supply Chain Officer and partners with executive leadership to balance regulatory risk and speed to market.

The successful candidate will possess deep IVD/medical device regulatory expertise, demonstrate cross-functional leadership, and guide strategy across multiple jurisdictions,