Senior Regulatory Affairs Lead: Global Submissions

Cordis; Irvine (CA); On-site; USD 89,000 - 119,000; Full time

Job summary

Cordis, in partnership with Selution, seeks an experienced Senior Regulatory Affairs Specialist in Irvine, CA. You will lead and author regulatory submissions, coordinate with engineering, QA, clinical teams, and regulators to ensure compliance with FDA, EU MDR, and other global requirements.

Responsibilities include PMA/IDE submissions, CE marking, and development of regulatory strategies for new and existing products.

Qualifications

• Strong experience with PMA authorship and submissions.
• Experience with a variety of submission types including: IDE, PMA, Design Dossier/Change Notifications, Shonin Applications
• Proven success with Class III device submissions and CE Marking.
• Experience with Class III Medical Devices.
• 5+ years of regulatory experience in medical device or pharma.
• 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.
• Act as a regulatory representative on large projects/programs to provide regulatory strategy and planning in line with Product Development Procedure and Quality System requirements
• Ability to communicate regulatory requirements and impact of regulations to project teams
• Assist with development of global regulatory strategies for new and changing products
• Direct interaction with regulatory agencies
• Prepares and submits PMA’s, PMA-A/S’s, IDE’s, Technical Files, Change Notifications
• Identifies and develops best practices within the Regulatory Affairs Department
• Supports internal and external audits
• Provides guidance and advice to other regulatory team members
• Supports regulatory compliance activities within business and corporation
• Keeps abreast of new and changing regulatory and quality system requirements

Skills

PMA submissions

Regulatory submissions

Class III devices

CE Marking

IDE submissions

Shonin Applications

English fluency

Education

Bachelor's degree in Science/Pharmacology or related field

Job description

Cordis, in partnership with Selution, seeks an experienced Senior Regulatory Affairs Specialist in Irvine, CA. You will lead and author regulatory submissions, coordinate with engineering, QA, clinical teams, and regulators to ensure compliance with FDA, EU MDR, and other global requirements.

Responsibilities include PMA/IDE submissions, CE marking, and development of regulatory strategies for new and existing products.