Regulatory Affairs Associate

Role

Regulatory Affairs Associate

Location

United States

Duration

Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products.

Key Responsibilities

• Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
• Affiliate in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
• Support regulatory strategy development for new products, product modifications, and market expansions.
• Maintain regulatory files, product registrations, licenses, and submission records.
• Review product labeling, promotional materials, and technical documentation for regulatory compliance.
• Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
• Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
• Affiliate with regulatory agency correspondence, inspections, audits, and information requests.
• Support change control assessments and evaluate regulatory impact of product or process changes.
• Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
• 1-3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
• Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
• Strong technical writing, documentation, and organizational skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Excellent verbal and written communication skills.