Regulatory Affairs Specialist

Job Summary

We are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory submissions, compliance activities, and product approval processes within the healthcare, pharmaceutical, biotechnology, or medical device industry. The ideal candidate will have strong knowledge of regulatory requirements and experience working with internal teams and regulatory agencies.

Responsibilities

• Prepare, review, and submit regulatory documents to agencies such as the FDA and other applicable authorities.

• Support new product registrations, renewals, amendments, and regulatory submissions.

• Maintain regulatory documentation, licenses, certifications, and product records.

• Monitor changes in regulatory requirements and communicate their impact to internal teams.

• Ensure products and processes comply with applicable laws, standards, and company procedures.

• Review product labeling, promotional materials, and technical documentation for regulatory compliance.

• Coordinate with quality, clinical, manufacturing, engineering, and research teams.

• Assist with responses to regulatory agency questions and information requests.

• Support audits, inspections, and regulatory assessments.

• Maintain submission timelines and track regulatory approvals.

• Assist with change-control activities and regulatory impact assessments.

• Support post-market compliance and reporting requirements when applicable.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related field.

• 2+ years of experience in regulatory affairs or a related compliance role preferred.

• Knowledge of FDA regulations and applicable industry standards.

• Strong documentation, organizational, and analytical skills.

• Excellent written and verbal communication skills.

• Ability to manage multiple regulatory activities and deadlines.

Preferred Experience

• Experience in the pharmaceutical, biotechnology, medical device, or healthcare industry.

• Familiarity with FDA, EMA, ICH, ISO, GMP, GCP, or related regulatory frameworks.

• Experience preparing regulatory submissions such as IND, NDA, ANDA, 510(k), PMA, or technical files, depending on the industry.

• Knowledge of electronic regulatory submission systems and document management tools.

• Experience supporting regulatory audits and inspections.

Skills

• Regulatory Affairs

• FDA Regulations

• Regulatory Submissions

• Regulatory Compliance

• Quality Systems

• GMP

• GCP

• ICH Guidelines

• ISO Standards

• Product Registration

• Labeling Compliance

• Document Management

• Change Control

• Regulatory Strategy

• Audit Support