Regulatory Affairs Intern
| Company | Veolia |
|---|---|
| Location | Arlington, TX, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Internship |
| Degrees | Bachelor’s |
| Experience Level | Internship |
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
Preferred Qualifications
- Experience in regulatory affairs or quality assurance, with a focus on medical devices