Compliance Specialist

hace 1 semana


Tijuana, Baja California, México Ws Audiology A tiempo completo

Ws Audiology is seeking a highly skilled Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.

We are offering a competitive salary of $60,000 per year, commensurate with experience.

About the Role:

The Compliance Specialist will be responsible for handling customer complaints related to medical devices. This includes capturing, assessing, and processing complaints in a timely manner, as well as conducting initial screenings to determine potential reportability and investigator location.

Additionally, the Compliance Specialist will perform follow-ups with investigators and stakeholders to ensure complaints are processed efficiently. You will also review complaint files to ensure documentation meets internal and external requirements, including GDP needs.

Requirements:

To be successful in this role, you must have working experience in complaint handling and customer quality, knowledge of operational processes, and experience with medical device complaint handling processes. Familiarity with FDA regulations and ISO13485 is also essential. You should be able to actively participate in and present during audits and inspections.

Benefits:

We offer a permanent contract with a full-time schedule, Monday to Friday, 8am-5pm. The position is based in our office, and we require a high level of English proficiency (written and spoken). We are an equal opportunities employer and welcome applications from all qualified candidates.



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