Regulatory Affairs Specialist for Medical Devices
3 weeks ago
Veolia Water Technologies & Solutions is seeking a highly motivated Regulatory Affairs Intern to join our team. As the Regulatory Affairs Intern, you will be responsible for supporting the Service Center by maintaining and organizing regulatory files, ensuring proper tracking of information and archiving of regulated documents.
About Us
We are part of Veolia Group, a global leader in water management. Our mission is to solve the world's most complex challenges related to water scarcity, quality, productivity, the environment, and energy. We're committed to diversity and equality, offering challenging careers with competitive benefits and flexible work arrangements.
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
- 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
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. If you're passionate about regulatory affairs and willing to learn, we encourage you to apply.
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