Compliant Handling Engineers

TechDigital Group; Alameda (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist with extensive experience in medical devices. This pivotal role involves overseeing complaint handling processes, ensuring compliance with regulatory standards, and actively participating in the development of quality systems. The ideal candidate will have a strong background in regulatory experience and complaint handling, along with excellent problem-solving and communication skills. Join a dynamic team dedicated to maintaining high standards of quality and compliance, where your contributions will directly impact the success of critical product lines in the medical device sector.

Qualifications

• 8 to 12 years of experience in Regulatory for Medical Devices.
• 4 to 6 years of experience in Complaint Handling.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Evaluate complaints against criteria for reportable events.

Skills

Regulatory experience

Complaint Handling

Problem-solving skills

Communication skills

Job description

Job Description:

1. Overall experience - 8 to 12 years of Regulatory experience in Medical Devices
2. 4 to 6 years of Complaint Handling in Medical Devices
3. Responsible for implementing and maintaining the effectiveness of the quality system.
4. Identifies and recruits talented staff to support and execute complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division.
5. Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.
6. Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements.
7. Champions and actively participates in development/improvements of complaint handling processes and procedures.
8. Monitor incoming complaints for increasing trends and alert management when a product issue is emerging.
9. Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data.
10. Ability to liaise with International Regulatory Authorities.
11. Ability to write and edit Regulatory/technical documents.
12. Problem-solving skills.
13. Good communication skills.