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Regulatory Affairs Officer - KHI at Rech International
Karachi, Punjab, Pakistan -
Full Time

Start Date

Immediate

Expiry Date

07 Oct, 26

Salary

0.0

Posted On

09 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

DRAP Regulations, Medical Device Registration, Licensing, Dossier Preparation, Regulatory Compliance, Communication Skills, Analytical Skills, Documentation, MS Office, Google Apps

Industry

Hospitals and Health Care

Description
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: 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. Qualifications & Experience: 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.
Responsibilities
The officer manages the registration and licensing of medical devices by preparing and submitting dossiers to DRAP. They act as the primary liaison between the company and regulatory authorities to ensure full compliance with legislation.