Global Regulatory Lead – Medical Devices & PMA Submissions

Cordis, LLC; Irvine (CA); Remote; USD 89,000 - 119,000; Full time

Job summary

Cordis, LLC in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to lead global submissions (PMA, IDE) and shape regulatory strategy for development and marketed products.

You will collaborate with engineering, QA, clinical and other teams to ensure compliance with QSR, ISO and MDSAP, and manage regulatory agency interactions on major programs. Strong leadership and Class III experience required.

Qualifications

• PMA submissions experience required.
• Bachelor’s degree in science/related field.
• 5+ years regulatory experience in medical devices or pharma.
• Experience with Class III device submissions and CE Marking.
• Experience with IDE, PMA, Design Dossier/Change Notifications, Shonin Applications.
• Fluent in English.

Responsibilities

• Prepare and manage global regulatory submissions (EU MDR, FDA IDE/PMA, LATAM, APAC).
• Advise on regulatory strategies for development and marketed products.
• Lead process improvement initiatives to increase regulatory efficiency.
• Ensure ongoing compliance with QSR, ISO, and MDSAP requirements.
• Interact with regulatory agencies on large projects/programs.
• Develop global regulatory strategies for new/changing products.
• Provide guidance to other regulatory team members.
• Stay abreast of new regulatory and quality system requirements.

Skills

PMA submissions

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Education

Bachelor’s degree in Science/Pharmacology or related field

Job description

Cordis, LLC in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to lead global submissions (PMA, IDE) and shape regulatory strategy for development and marketed products.

You will collaborate with engineering, QA, clinical and other teams to ensure compliance with QSR, ISO and MDSAP, and manage regulatory agency interactions on major programs. Strong leadership and Class III experience required.