Regulatory Affairs Pharmacist (Medical Equipment and Supplies Industry)

Job Summary

The Regulatory Affairs Pharmacist is responsible for ensuring that the company's medical devices, medical equipment, healthcare supplies, and related products comply with all applicable regulatory requirements. The role involves preparing and maintaining regulatory submissions, securing licenses and permits, coordinating with regulatory authorities, monitoring regulatory updates, and supporting quality and compliance initiatives to ensure uninterrupted business operations.

Key Responsibilities

• Ensure compliance with all applicable laws, regulations, and guidelines governing medical devices, medical equipment, and healthcare supplies.
• Maintain company licenses, permits, registrations, and certifications.
• Monitor changes in regulatory requirements and advise management on compliance implications.
• Develop and implement regulatory policies and procedures.

• Prepare, submit, and track product registration applications and renewals.
• Compile and maintain technical documentation, product dossiers, and regulatory files.
• Coordinate with manufacturers, suppliers, and regulatory agencies regarding product registrations and approvals.
• Ensure timely renewal of product registrations and business permits.

• Maintain accurate regulatory records and documentation.
• Review product labels, packaging, promotional materials, and marketing claims for regulatory compliance.
• Prepare reports and documentation required by regulatory authorities.
• Ensure document control procedures are followed.

• Serve as the primary point of contact with regulatory authorities.
• Coordinate inspections, audits, and regulatory assessments.
• Respond to regulatory inquiries, deficiency letters, and compliance issues.
• Facilitate submission of post-market surveillance reports and other regulatory requirements.

• Collaborate with Quality Assurance and Operations teams to ensure regulatory compliance throughout the product lifecycle.
• Support internal audits and external inspections.
• Participate in corrective and preventive action (CAPA) activities.
• Assist in product recalls, field corrective actions, and risk management activities when necessary.

• Provide regulatory guidance and training to internal departments.
• Monitor industry trends and regulatory developments.
• Communicate regulatory updates and compliance requirements to stakeholders.

• Bachelor's Degree in Pharmacy.
• Licensed Pharmacist.
• Minimum of 2–3 years of experience in Regulatory Affairs, preferably in medical devices, medical equipment, healthcare supplies, or pharmaceutical industries.
• Knowledge of regulatory requirements applicable to medical devices and healthcare products.
• Experience in product registration and regulatory submissions is preferred.
• Proficient in Microsoft Office applications and regulatory documentation systems.

• Strong knowledge of regulatory compliance and documentation.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to interpret regulations and apply them effectively.
• Project management and multitasking abilities.
• Analytical and problem-solving skills.

• Timely approval and renewal of product registrations and licenses.
• Successful completion of regulatory inspections and audits.
• Compliance with applicable regulatory requirements.
• Accuracy and completeness of regulatory documentation.
• Timely resolution of regulatory issues and submissions.