Quality officer

The Regulatory Affairs & Compliance Executive will be responsible for developing, implementing, and maintaining all compliance documentation required for licensing a medical device manufacturing facility in Pakistan, ensuring adherence to local regulations and international standards (CE marking for European export).

Key Responsibilities

Regulatory Licensing & Registration

• Lead the preparation and submission of all documentation required for obtaining manufacturing licenses from the Drug Regulatory Authority of Pakistan (DRAP)
• Develop and maintain establishment license applications and renewal documentation
• Prepare product registration dossiers for medical devices in accordance with Pakistani regulations
• Serve as primary liaison with DRAP and other regulatory bodies throughout the licensing process
• Monitor regulatory timelines and ensure timely submission of all required documentation

Quality Management System Documentation

• Develop and implement Quality Management System (QMS) documentation in compliance with ISO 13485:2016 standards
• Create and maintain Standard Operating Procedures (SOPs) for all manufacturing, quality control, and distribution processes
• Prepare quality manuals, work instructions, and forms required for medical device manufacturing
• Establish document control systems and procedures to ensure version control and traceability
• Develop risk management documentation in accordance with ISO 14971

CE Marking Compliance

• Prepare technical documentation files for CE marking under the Medical Device Regulation (MDR 2017/745)
• Develop Declaration of Conformity and ensure compliance with applicable harmonized standards
• Coordinate with Notified Bodies for conformity assessment procedures where required
• Maintain post-market surveillance documentation and vigilance reporting systems
• Ensure ongoing compliance with European regulatory requirements for medical device exports

Compliance Documentation & Reporting

• Create and maintain batch manufacturing records and device history files
• Develop complaint handling procedures and adverse event reporting systems
• Prepare validation protocols and reports (IQ/OQ/PQ) for equipment and processes
• Establish supplier qualification and vendor management documentation
• Create internal audit programs and maintain audit records
• Develop corrective and preventive action (CAPA) documentation systems

Regulatory Intelligence & Strategy

• Monitor changes in local and international medical device regulations
• Assess regulatory impact of new requirements on manufacturing operations
• Develop regulatory strategies for new product introductions
• Provide regulatory guidance to cross-functional teams including R&D, manufacturing, and quality
• Maintain regulatory databases and tracking systems

Required QualificationsEducation

• Bachelor's degree in Pharmacy, Life Sciences, Biomedical Engineering, or related field (Master's degree preferred)
• Professional certification in Regulatory Affairs (RAC) is highly desirable

Experience

• Minimum 0-7 years of experience in regulatory affairs within the medical device or pharmaceutical industry
• Proven experience with DRAP licensing procedures and medical device regulations in Pakistan
• Direct experience with ISO 13485 implementation and CE marking processes
• Track record of successful regulatory submissions and approvals

Technical Skills

• Comprehensive knowledge of Pakistani medical device regulations and DRAP requirements
• Expert understanding of EU MDR 2017/745 and CE marking requirements
• Proficiency in ISO 13485, ISO 14971, and other relevant quality standards
• Strong technical writing skills with ability to create clear, compliant documentation
• Experience with electronic Quality Management Systems (eQMS) and document management software

Competencies

• Exceptional attention to detail and organizational skills
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills in English and Urdu
• Ability to work independently and manage multiple projects simultaneously
• Strong interpersonal skills for effective liaison with regulatory authorities
• Strategic thinking with ability to anticipate regulatory challenges
• Project management capabilities with focus on deadline adherence

Working Conditions

• Full-time position based at manufacturing facility
• May require occasional travel to regulatory offices and industry conferences
• Interaction with regulatory authorities, auditors, and cross-functional teams

Reporting Structure

Reports to: Director Quality Operations

Key Performance Indicators

• Timely acquisition and maintenance of all required licenses and registrations
• Zero non-conformances during regulatory inspections and audits
• On-time completion of regulatory submissions
• Successful CE marking achievement for export products
• Maintenance of QMS documentation currency and accuracy

How to Apply: Interested candidates should submit their CV, cover letter, and relevant certifications.

Job Types: Full-time, Internship, Fresher

Work Location: In person