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Regulatory Affairs Intern

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Veolia

Oct 16

Applications are closed

  • Internship
    Full-time
    Summer Internship
  • Arlington

Requirements

  • Currently enrolled in an undergraduate program with a focus in BioChemistry, Chemistry, Biology, or another related field
  • Experience working with collaborative spreadsheet software (either Google Sheets or Microsoft Excel)
  • Strong teamwork & communication skills
  • Ability to prioritize and maintain deliverables in a fast-paced work environment

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

FAQs

What is the role of the Regulatory Affairs Intern at Veolia Water Technologies & Solutions?

The Regulatory Affairs Intern will provide support to the Service Center by maintaining and organizing regulatory files, auditing correspondence, preparing submissions, and ensuring compliance with FDA and ISO regulations related to the water treatment industry.

What educational background is preferred for this internship?

The ideal candidate should be currently enrolled in an undergraduate program with a focus in BioChemistry, Chemistry, Biology, or another related field.

What skills are required for the Regulatory Affairs Intern position?

Required skills include experience with collaborative spreadsheet software (Google Sheets or Microsoft Excel), strong teamwork and communication skills, and the ability to prioritize and maintain deliverables in a fast-paced work environment.

Will the intern have opportunities to collaborate with other teams?

Yes, the intern will coordinate with Quality Assurance, Plant Manager, and Quality Control teams to review technical documents and ensure compliance with FDA submissions.

Can you provide information on the types of tasks the intern will be responsible for?

The intern will be responsible for auditing regulatory correspondence files, preparing submissions and change orders, developing regulatory files, assisting in audits, supporting labeling claim reviews, and helping with process validations among other duties.

Is there an emphasis on diversity within the company?

Yes, Veolia is committed to diversity and inclusivity, and they give equal consideration to all applications without discrimination.

What kind of experience is valuable for this internship?

Previous experience in regulatory affairs or quality assurance, particularly with a focus on medical devices, is valuable for this role.

Are there opportunities for professional development during the internship?

Yes, this internship offers an excellent opportunity to gain hands-on experience in the regulatory aspects of the water treatment industry and contribute to compliance and documentation processes.

How does the company handle confidential information?

All information provided by applicants will be kept confidential according to EEO guidelines.

What are the expected working conditions for the intern?

The intern will work in a strong technical service environment, collaborating closely with experienced professionals and participating in various regulatory compliance activities.

Veolia is the benchmark company for ecological transformation.

Energy
Industry
10,001+
Employees
1853
Founded Year

Mission & Purpose

Veolia is a leading environmental services company that specialises in providing solutions for water, waste, and energy management. They offer a wide range of services, including water treatment and supply, waste collection and recycling, energy generation, and resource management. Veolia's ultimate mission is to contribute to the sustainable development of communities and industries by promoting the circular economy and reducing the environmental impact of their clients' operations. Their purpose lies in preserving natural resources, reducing waste, and optimising resource usage through innovative and responsible solutions. By harnessing their expertise in environmental management and sustainable practices, Veolia aims to create a more resilient and resource-efficient future, supporting the well-being of communities and industries while safeguarding the planet for future generations.

Culture & Values

  • Community Spirit

  • Customer Focus

  • Innovation

  • Respect

  • Responsibility

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