Regulatory Affairs Officer

Regulatory Officer Job Description

Job Title

Regulatory Officer

Department

Regulatory Affairs

Reports To

Regulatory Affairs Manager

Job Summary

The Regulatory Officer is responsible for ensuring that the intraocular lens (IOL) manufacturing facility complies with all relevant regulatory requirements and standards, including ISO 13485. This role involves preparing and submitting regulatory filings, maintaining regulatory documentation, and supporting the implementation of the quality management system (QMS). The Regulatory Officer ensures that products meet regulatory requirements and facilitates the timely approval of new products and modifications.

Key Responsibilities

• Develop and Implement Regulatory Strategies:
• Develop regulatory strategies aligned with business objectives and product development plans.
• Assess regulatory requirements, timelines, and risks to facilitate the timely and successful market approval of new products and modifications.
• Prepare and Submit Regulatory Filings:
• Prepare and submit regulatory filings, applications, and dossiers to obtain marketing authorizations, approvals, or clearances for IOL products.
• Ensure compliance with regulatory requirements for pre-market notifications, pre-market approvals, CE marking applications, and other regulatory submissions.
• Maintain Regulatory Documentation:
• Maintain accurate and up-to-date regulatory documentation, including technical files, design dossiers, and regulatory submissions.
• Ensure documentation is in compliance with ISO 13485 and other relevant regulatory standards.
• Monitor Regulatory Changes and Updates:
• Monitor changes in regulations, guidance documents, and standards affecting IOL manufacturing and distribution.
• Conduct regulatory intelligence activities to stay informed about evolving regulatory requirements, industry trends, and competitor practices.
• Ensure Compliance with Quality Management System (QMS):
• Support the implementation and maintenance of the QMS to ensure compliance with ISO 13485.
• Establish procedures, processes, and documentation controls to support regulatory compliance and product quality assurance.
• Conduct Labeling and Packaging Compliance:
• Ensure that labeling and packaging of IOL products comply with regulatory requirements and standards.
• Review and approve labeling content, instructions for use, and product packaging designs to ensure accuracy, clarity, and compliance with labeling regulations.
• Oversee Post-Market Compliance:
• Oversee post-market surveillance activities to monitor compliance with regulatory requirements, including adverse event reporting, field safety corrective actions (recalls), and post-market surveillance studies.
• Ensure timely and accurate reporting of adverse events and other post-market activities.
• Collaborate with Cross-Functional Teams:
• Work with production, quality assurance, and engineering teams to ensure regulatory requirements are met.
• Provide regulatory guidance and support during product development, validation, and manufacturing processes.
• Conduct Internal Audits and Inspections:
• Participate in internal audits and inspections to ensure compliance with regulatory standards and QMS requirements.
• Identify areas for improvement and implement corrective and preventive actions (CAPAs).
• Provide Training and Education:
• Provide training on regulatory requirements, processes, and best practices to staff.
• Foster a culture of regulatory awareness and compliance within the organization.

Qualifications

• Bachelors degree in Regulatory Affairs, Quality Assurance, Engineering, or a related field.
• Minimum of 3-5 years of experience in regulatory affairs, preferably in the medical device or pharmaceutical industry.
• Knowledge of ISO 13485, FDA, and other relevant regulatory standards and requirements.
• Strong analytical, problem-solving, and communication skills.
• Proficiency in using regulatory submission software and tools.
• Ability to work collaboratively with cross-functional teams.

Job Type: Full-time

Pay: $15,000.00 - $25,000.00 per month

Benefits:

• Medical Insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• 13th month salary

Education:

• Bachelors Degree (Preferred)

Experience:

• Regulatory: 1 year (Preferred)

Language:

• English (Preferred)

Work Location: In person

Information :

• Company : Laurus Optics LTD.
• Position : Regulatory Affairs Officer
• Location : Kwai Chung, New Territories
• Country : HK