Regulatory Affairs Specialist At 3M
Here, you will make an impact by:
Ensuring full Regulatory Compliance in doing health care business in Egypt and Levant.
Fulfilling the requirement to secure registrations, imports permission, and shipments clearence by a regulatory affairs professional who is based in Egypt to secure and mainatin the health care business.
Supporting the business team to achieve yearly business objectives
Providing regulatory intelligence and obtain approvals for regulatory product submissions
Performing all the regulatory activities necessary for registering 3M health care products in Egypt and Levant as per the local regulations and maintain their licenses.
Supporting regulatory activities for business tender participation
Early regulatory assessment and involvement in the New Products Introduction process.
Performing all activities related to products’ quality (Vigilance, pharmacovigilance, compliant handling, recalls …)
Collaborating with the regulatory team in the headquarters to fulfil the local regulatory requirements
Establishing and maintain a network with the key regulatory bodies in Egypt and Levant
Participating in lobbing regulatory activities
Monitoring emerging changes affecting Medical devices and pharmaceutical regulations in Egypt and Levant
You will report to the Senior Manager Regulatory and quality compliance for MEA and will be located in Egypt.
Your Skills and Expertise
To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications:
Pharmacist, with basic knowledge of medical device regulation in Egypt and Levant
Experience in Regulatory submission and approval
Excellent negation skills
Customer focused approach
Result driven person
Good English knowledge
Arabic knowledge is a plus