What are the responsibilities and job description for the Regulatory Affairs Expert - Medical Devices position at GTT Healthcare?
Job Summary
We are seeking a Regulatory Affairs Expert - Medical Devices to manage regulatory tasks related to health authority notifications, submissions, and registrations. This role ensures compliance with global medical device regulations while aligning site regulatory strategies with overall corporate goals. With minimal supervision, you will play a key role in regulatory compliance, documentation management, and audits.
If you have experience in In Vitro Diagnostic Regulation (IVDR) and a strong understanding of FDA 21 CFR 820, CMDR SOR 98-292, and ISO 13485:2016, we encourage you to apply!
Key Responsibilities
- Monitor and analyze regulatory standards and regulations, conducting reviews and analyses as requested. Assist and advise on regulatory registrations, listings, and compliance, with a particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), while maintaining compliance with FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other International Medical Device Regulations.
- Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals.
- Maintain a library/database of technical documentation to track regulatory updates and ensure compliance.
- Review updated documentation requirements and perform a thorough review, ensuring any necessary updates are made while disseminating relevant information across the site.
- Analyze new registration requirements to assess their impact on business operations and document findings accordingly.
- Manage regulatory reviews for CAPA investigations, adverse events, validations, and general projects.
- Respond to internal and external customer regulatory requests and inquiries, ensuring timely and accurate information is provided.
- Support preparation for and participate in audits conducted by regulatory bodies to ensure compliance with regulatory requirements.
- Support recall or notification actions and execute regulatory vigilance reporting as required.
- Act as a liaison between the site and internal/external in-country representatives to ensure regulatory alignment.
- Maintain records of registration activities and license changes while adhering to Good Documentation Practices (GDPs).
Job Type: Contract
Pay: $33.28 - $35.28 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
Salary : $33 - $35
