Regulatory Affairs Specialist
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Key skills for this role
About the Role
A medical equipment distributor in the UAE seeks a Regulatory Affairs Pharmacist to classify and register medical devices with the Ministry of Health. Requires a B.S.
Key Skills for This Role
Responsibilities
- Classifying and registering Medical Devices with the UAE Ministry of Health
- Applying for Import Permits and managing shipment clearance at port
- Following up with distributors and manufacturers for required documents
- Taking appropriate actions for Field Actions and Product Recalls
- Ensuring compliance with UAE MOH regulations for importing and distributing medical devices
- Acquiring quality certificates (ISO, GMP, FSC, CEC) from manufacturers as required
- Managing registration and renewal of all company MOH Licenses
- Advising on regulatory requirements for each Medical Device
- Liaising with regulatory authorities during inspections
- Ensuring data reports and quality standards are met within given timeframes
Requirements
- B.S. Pharmacy or Pharm D degree
- 1 3 years of relevant experience in the UAE
- Active UAE MOH Pharmacist License
Full Job Posting
Overview
- A reputable medical equipment and surgical consumables distributor in the UAE is seeking a qualified Regulatory Affairs Pharmacist to join our growing team on an immediate basis.
Minimum Requirements
- B.S. Pharmacy or Pharm D degree
- 1 3 years of relevant experience in the UAE
- Active UAE MOH Pharmacist License (mandatory)
Duties & Responsibilities
- Classifying and registering Medical Devices with the UAE Ministry of Health
- Applying for Import Permits and managing shipment clearance at port
- Following up with distributors and manufacturers for required documents
- Taking appropriate actions for Field Actions and Product Recalls
- Ensuring compliance with UAE MOH regulations for importing and distributing medical devices
- Acquiring quality certificates (ISO, GMP, FSC, CEC) from manufacturers as required
- Managing registration and renewal of all company MOH Licenses
- Advising on regulatory requirements for each Medical Devices
- Liaising with regulatory authorities during inspections
- Ensuring data reports and quality standards are met within given timeframes
Skills
- Good working knowledge of UAE MOH laws and medical device regulations
- Excellent communication and interpersonal skills
- Strong leadership and decision making abilities
- Highly organized with a commitment to succeed
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