Regulatory Affairs Specialist II
Aviso de fuente externaen Integer Holdings Corporation
Support regulatory submissions, product registrations, document management, customer requests, and quality system audits for Integer Holdings Corporation.
Salario
No especificado
Ubicación
Santo Domingo Este, República Dominicana
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Regulatory Affairs Specialist II
Santo Domingo Este, República Dominicana
Descripción del empleo
About the role
The primary purpose of this role is to support Regulatory Affairs managers and department management by capturing, archiving, and publishing regulatory documents. You will develop strategies and prepare submissions for national and international product registrations, and prepare and maintain regulatory files, reports, and databases.
You will adhere to Integer’s Values and safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Responsibilities
- Regulatory submissions and approvals: Prepare national and international regulatory submissions for Integer owned devices and support product submissions by consulting multiple sources for information.
- Review Change Requests requiring regulatory review and approval to ensure compliance with national and international government regulations.
- Prepare and maintain no-file decisions, external regulatory databases such as FDA FURLS, GUDID, and EUDAMED, and product files in accordance with Integer quality system requirements and department procedures.
- Customer support: Coordinate reviews and responses to customer requests and queries about processes and products, and maintain tracking logs.
- Participate in customer notifications of changes and help maintain the related tracking log.
- Obtain external regulatory documents, such as CFG’s and CFS’s, for customer requests and facilitate their legalization, authentication, or apostilling as required.
- External and internal audits: Perform and support internal quality system audits in accordance with Integer quality management...
Datos clave
- Prepares national and international submissions for Integer owned devices.
- Maintains regulatory files, reports, databases, and product files.
- Coordinates responses to customer requests and queries about processes and products.
Preguntas frecuentes
What does this role involve?
It supports Regulatory Affairs managers and department management with regulatory documents, submissions, product registrations, files, reports, and databases.
What regulatory submissions does the role prepare?
The role prepares national and international regulatory submissions for Integer owned devices.
Does the role support customer requests?
Yes. It coordinates reviews and responses to customer requests and queries related to processes and products, and maintains tracking logs.