Regulatory Affairs Specialist

3 days ago

Arlington, Virginia, United States Veolia Environnement SA Full time
Job Title: Regulatory Affairs Intern

Veolia Water Technologies & Solutions is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of regulatory strategies.

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
Qualifications:
  • 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

Veolia is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.

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