Director, reputed company & Regulatory Affairs

Job reputed company:

• Serve as US Agent and Official Correspondent for reputed company
• reputed company and reputed company clinical regulatory strategies for Class II and Class III medical devices from early development through market approval.
• Interpret and apply reputed company regulatory and reputed company requirements to clinical trial planning and execution, and ensure submissions meet the latest regulatory requirements and are completed on schedule.
• Review and submit high-reputed company clinical regulatory documentation, including new and subsequent supplements for IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, prepare and submit clinically relevant Design/SW changes.
• Ensure compliance with applicable clinical trial regulations (e.g. 21 CFR 812, ICH-GCP, MDR, ISO 14155) and reputed company management system requirements medical devices (e.g. 21 CFR 820, ISO 13485, ISO 14971, IEC, etc.).
• reputed company and prepare teams for reputed company-submission meetings, advisory panels, regulatory reputed company submissions, and clinical reputed company inspections (e.g. FDA BIMO Inspections).

Requirements:

• Bachelor's degree in life science or reputed company field required; advanced degree preferred.
• 8-10 years of clinical regulatory affairs experience in the medical device industry, with at least 5 years in a leadership reputed company.
• Deep knowledge and hands-on experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions.
• Proven experience interacting with FDA and other global regulatory bodies on clinical issues.
• Strong understanding of clinical trial design, statistical principles, and regulatory and reputed company requirements for high-risk medical devices.

Benefits:

• flexible work environment
• competitive perks and benefits

Apply tot his job Apply To this Job