Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist

Irvine California

As a Senior Staff Regulatory Affairs Specialist you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development quality and clinical teams. This role offers meaningful impact technical depth and the opportunity to shape regulatory outcomes that enable innovation and market access.

Work Flexibility: Hybrid or Onsite
Hybrid candidates must reside within commuting distance of Irvine CA and be able to work onsite several days per week.

What You Will Do

• Assess global regulatory intelligence to support the development and maintenance of local regional and global regulatory strategies across the product lifecycle.
• Evaluate regulatory requirements related to product classification jurisdiction submission pathways and compliance activities to enable market access.
• Provide regulatory guidance to product development teams across concept development manufacturing marketing and postmarket phases.
• Anticipate regulatory risks and obstacles and develop solutions to support timely product approvals and lifecycle changes.
• Prepare submit and manage regulatory submissions and communications with regulatory authorities in accordance with applicable requirements.
• Monitor regulatory authority review progress and support interactions such as meetings panels and advisory engagements.
• Assess quality preclinical and clinical documentation to ensure acceptability for regulatory filings and alignment with regulatory strategy.
• Support the development implementation and training of regulatory procedures to strengthen organizational compliance.
• Development and review of advertising/promotional collateral to support commercial needs.

What You Will Need

Required Qualifications

• Bachelors degree in Engineering Science or a related discipline.
• 6 years of experience in regulatory affairs within a regulated industry.
• Experience supporting regulatory submissions and approvals across the product lifecycle.

Preferred Qualifications

• Masters degree in Regulatory Science or a related field.
• Regulatory Affairs Certification (RAC).
• Experience interacting directly with regulatory authorities in the United States or international markets.

• $126600 - $210900 USD Annual