Remote Senior Regulatory Affairs Leader — Post-Market

Illumina; California (MO); Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Bonus program

Equity opportunities

Health benefits

Job summary

Illumina in the United States seeks a Senior Regulatory Affairs Specialist to drive post-market compliance for in vitro diagnostic (IVD) products across domestic and international markets. The role requires developing regulatory strategies, coordinating submissions, and guiding cross-functional teams to ensure regulatory alignment.

You will lead complex regulatory plans, support MDR/recall decisions, and ensure ongoing compliance with global requirements while contributing to process

Qualifications

• Minimum 5 years of related experience with a Bachelor's degree; or 3 years with a Master's; or a PhD without experience.
• Strong understanding of FDA regulations and international requirements (EU, Canada, Australia, etc.).
• Experience in post-market regulatory compliance for IVD devices.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Represents the RA function on cross-functional project teams.
• Interprets regulations and creates regulatory strategies for domestic and international markets.
• Develops and executes regulatory plans for complex projects and maintenance of approvals/licenses.
• Prepares submission packages and supports labeling and study plans.
• Provides regulatory guidance and training to internal departments and partners.

Skills

Regulatory affairs

FDA regulations

Cross-functional collaboration

Communication skills

Leadership

Education

Bachelor's degree

Master's degree

PhD

Tools

MS Office

Regulatory databases

Document management systems

Job description

Illumina in the United States seeks a Senior Regulatory Affairs Specialist to drive post-market compliance for in vitro diagnostic (IVD) products across domestic and international markets. The role requires developing regulatory strategies, coordinating submissions, and guiding cross-functional teams to ensure regulatory alignment.

You will lead complex regulatory plans, support MDR/recall decisions, and ensure ongoing compliance with global requirements while contributing to process