We are looking for a Regional Regulatory Affairs Manager to work in Dubai who will be responsible for overseeing RA departments in the UAE, KSA, and Turkey. The candidate must:
- Hold a University degree in Medical, Biomedical, Biochemistry, Biotechnology or relevant scientific education. Post graduate/MSc degree and/or Qualified Pharmacist will be preferred
- Have at least 7 to 10 years in Regulatory Affairs, Regulatory Compliance, with significant depth of experience within the medical device industry
- Have at least 5 years of experience in leading people and organizations, and is able to independently drive impact-full initiatives/projects from start to finish
- Have proven knowledge with Regulations of FDA, CE, ISO laboratory and manufacturer requirements
- Is fluent in English both verbally and in writing. Arabic is a plus, or any spoken language in the market
The candidates responsibilities shall be:
- Representing the company in all the Regulatory Audit/Inspection visits, maintain all records for Audit/ Inspection visits as per Corporate Records Management and follow up all the required corrective actions through progress sheets
- Assuring timely regulatory clearances and registrations for new product launches, renewals to ensure timely market access, continuous product availability and compliance.
- Collaborating with the Product Quality and Safety lead regarding the requirements for Adverse event reporting and recall management ensuring compliance to regional regulations
- Aligning with key cross-functional partners within the organisation at various levels involving matters between functional areas, other departments or org units, or customers and the company (e.g. Marketing, Product Management, Supply Chain)
Sthree UAE is acting as an Employment Agency in relation to this vacancy.