Kinetic is working with a leading Medical Device company who are hiring a Regulatory Affairs Specialist to be based in Egypt.

The main responsibilities will include but not limited to:

• Ensures timely preparation, submission, and appropriate follow-up of new applications to the local authorities.
• Maintenance of assigned, authorized products through timely submission of variations, and renewal applications.
• Track and follow up with the submission of regulatory files (renewals, variations, etc.)
• Ensures high-quality labeling translation and artwork management.
• Updated on relevant local regulations and guidelines.
• Maintain a positive relationship with internal and external regulatory contacts.

Skills

To be successful you will need to meet the following:

• Only Candidates currently based in Egypt will be considered.
• Bachelor’s Degree in Pharmacy or related field.
• Minimum 3-5 years regulatory experience.
• Regulatory affairs experience within the Medical Devices Industry is a must.
• Good knowledge of regulatory requirements, regulations & guidelines for medical devices.
• Scientific knowledge and strong attention skills.
• Must have excellent verbal and written communication skills in English and Arabic.