Regulatory Affairs Officer - KHI
RECH INTERNATIONAL
Date: 3 weeks ago
City: Karachi
Contract type: Full time
Regulatory Affairs Officer - Karachi
The Regulatory Affairs Officer ensures compliance with DRAP regulations for licensing, registration, and marketing of medical devices, acting as the key link between Rech International and regulatory authorities.
Job Type: Full time - Onsite
Working hours: 9am - 6pm
Working Days: Monday - Saturday
Market Competitive Salary & Benefits
Key Responsibilities:
The Regulatory Affairs Officer ensures compliance with DRAP regulations for licensing, registration, and marketing of medical devices, acting as the key link between Rech International and regulatory authorities.
Job Type: Full time - Onsite
Working hours: 9am - 6pm
Working Days: Monday - Saturday
Market Competitive Salary & Benefits
Key Responsibilities:
- Prepare, submit, and follow up on DRAP registration/notification dossiers.
- Manage licensing of medical devices (Orthopedic Implants, OMF, Neuro, Spine, Knee & Hip Joints).
- Liaise with DRAP officials and internal stakeholders to ensure timely approvals.
- Monitor and implement changes in DRAP regulations, keeping records updated.
- Ensure compliance of product portfolio with DRAP guidelines and legislation.
- Provide regulatory input, reporting, and support for internal teams and external partners.
- Bachelors degree in Sciences; Masters preferred.
- 3-4 years experience in Regulatory Affairs with DRAP submissions.
- Strong knowledge of DRAP laws and guidelines for medical devices.
- Proficiency in MS Office & Google Apps.
- Excellent communication, analytical, and documentation skills.
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