Regulatory Affairs Intern

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

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