Regulatory Affairs Specialist, Intelligence & Compliance

Regulatory Jobs; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs in California. This role supports the Corporate Regulatory Affairs team and cross-functional groups to enable patient access to life-saving devices and therapies.

The position involves regulatory change assessment, globalization of compliance programs, and collaboration with international counterparts.

Qualifications

• Bachelor’s degree and minimum of 3 years of Regulatory Affairs experience in a highly regulated industry OR Master’s degree with at least 1 year of Regulatory Affairs experience; or equivalent work experience.

Responsibilities

• Provide regulatory support and leadership to global Regulatory Affairs teams and cross-functional groups.
• Support regulatory process improvements and ensure compliance across business units and international affiliates.
• Gather information to advise on global regulatory strategies and contingencies for product approvals.
• Assist on regulatory changes and responses from international affiliates and FDA device listings.

Skills

Regulatory affairs

Regulatory compliance

Cross-functional collaboration

Microsoft Office

Education

Bachelor’s degree

Master’s degree

Tools

Microsoft Office

ISO 13485 knowledge

Job description

Edwards Lifesciences is seeking a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs in California. This role supports the Corporate Regulatory Affairs team and cross-functional groups to enable patient access to life-saving devices and therapies.

The position involves regulatory change assessment, globalization of compliance programs, and collaboration with international counterparts.