Regulatory Affairs Intern Job at Veolia WTS, Arlington, TX

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  • Veolia WTS
  • Arlington, TX

Job Description

Job Description

As the Regulatory Affairs Intern, you will be joining a strong technical service environment. In this role, you will have an opportunity to work alongside experienced professionals as you provide support to the Service Center, ensuring maintenance and organization of regulatory files for proper tracking of information and archiving of regulated documents. 

The ideal candidate will have experience in regulatory affairs or quality assurance, with a focus on medical devices. This internship offers an excellent opportunity to gain hands-on experience in the regulatory aspects of the water treatment industry while contributing to critical compliance and documentation processes.

Key Responsibilities:

Audit and update regulatory correspondence files, logs, and submission archives

Prepare and support submissions and change orders, including gathering technical documentation for medical device registrations

Develop and maintain regulatory files and documents in compliance with FDA and ISO regulations

Assist in the preparation of regulatory strategies to ensure FDA compliance

Participate in plant-initiated audits and suggest corrective and preventive actions

Support labeling claim reviews to ensure compliance with US regulations

Coordinate with Quality Assurance, Plant Manager, and Quality Control teams to review technical documents for FDA submission

Document and write procedures for medical device barcoding processes in alignment with FDA requirements

Assist in the validation of CAPA processes, including documenting changes to product lines and plant renovations

Conduct gap analysis between 510(k) and ISO 13485 standards, identifying gaps and developing mitigation plans

Help prepare Standard Operating Procedures (SOPs)

Assist in identifying, addressing, and eliminating causes of non-compliance

Support the preparation of process validation, analytical method validation, and coordinate manuals for FDA review

Job Tags

Part time,

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