Job Description:

We are a leading healthcare and medical device organization dedicated to enhancing patient care through innovative technologies. We seek a skilled Biomedical Engineer specializing in Medical Imaging, with expertise in regulatory compliance and experience working with the Drug Regulatory Authority of Pakistan (DRAP).

POSITION OBJECTIVE:

Ensure compliance with DRAP regulations for medical imaging devices by managing registration, post-market surveillance, adverse event reporting, quality control, regulatory submissions, and storage facility inspections.

KEY RESPONSIBILITIES:

• Medical Device Registration:
  Prepare and submit documentation to DRAP for medical imaging device approval, ensuring compliance with all regulatory requirements.
• Post-Market Surveillance (PMS):
  Monitor device performance and safety post-market, adhering to DRAP’s surveillance guidelines.
• Adverse Event Reporting:
  Report adverse events and malfunctions to DRAP promptly, ensuring regulatory compliance.
• Quality Control & Assurance:
  Conduct inspections and testing to meet DRAP and ISO 13485 quality standards.
• Regulatory Submissions:
  Submit clinical evaluation reports (CER) and regulatory documents for device approval and maintenance.
• Storage Facility Inspection:
  Ensure storage facilities comply with DRAP regulations for safe device handling and integrity.

KEY REQUIREMENTS:

• DRAP Compliance: Strong knowledge of DRAP regulations, registration, and approval processes.
• FDA/DRAP Standards: Understanding of local and international regulatory requirements for medical imaging devices.
• Quality Management (QMS): Experience with ISO 13485 and DRAP QMS standards for quality control.
• Labeling & Packaging: Expertise in DRAP-compliant labeling and packaging standards.
• Regulatory Submissions: Experience in preparing CERs, technical documents, and test data for DRAP submissions.
• Post-Market Compliance: Knowledge of surveillance and adverse event reporting per DRAP guidelines.
• Storage Facility Inspection: Ability to inspect and ensure compliance with DRAP storage regulations.

Qualifications:

Education: Bachelor’s or Master’s degree in Biomedical Engineering.

Experience: At least 1-2 years of experience in medical imaging and DRAP regulatory compliance.

Skills: Strong analytical, problem-solving, and communication skills. Proficiency in medical imaging software (e.g., MATLAB, Python) and regulatory submission tools.