Regulatory Affairs Manager — Medical Devices

CorDx; San Diego (CA); Vor Ort; CAD 168.000 - 223.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Medical, dental, and vision insurance

401(k) plan

Flexible paid time off (PTO)

Additional substantial benefits

Zusammenfassung

CorDx is seeking a Regulatory Affairs Manager to lead regulatory submissions and risk assessment for medical device products. You will coordinate 510(k) submissions, technical files, and regulatory documentation across functions to secure approvals and clearances.

You will liaise with FDA and other authorities, ensure compliance with FDA 21 CFR Part 820 and ISO 13485, and guide product teams through lifecycle regulatory needs, audits, and documentation workflows.

Qualifikationen

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
• Master’s degree preferred.
• 5–7 years of regulatory affairs experience within the medical device or IVD industry.
• Experience with FDA 510(k) submissions and regulatory documentation processes.
• Experience interacting with FDA and other regulatory agencies preferred.

Aufgaben

• Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
• Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
• Provide regulatory guidance to product development teams.
• Stay current on regulatory changes and assess impact on processes.
• Maintain documentation of all regulatory submissions and correspondence.
• Support regulatory agency meetings, audits, and inspections.
• Collaborate with R&D, Quality, and Operations to meet regulatory deliverables.

Kenntnisse

FDA regulations 21 CFR 820

ISO 13485

Regulatory submissions

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Regulatory Affairs or related field

Master’s degree preferred

Jobbeschreibung

CorDx is seeking a Regulatory Affairs Manager to lead regulatory submissions and risk assessment for medical device products. You will coordinate 510(k) submissions, technical files, and regulatory documentation across functions to secure approvals and clearances.

You will liaise with FDA and other authorities, ensure compliance with FDA 21 CFR Part 820 and ISO 13485, and guide product teams through lifecycle regulatory needs, audits, and documentation workflows.