About the job
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join the team in Dubai. The primary focus of this role is to manage and oversee the preparation and maintenance of documentation required for CE marking of medical devices, ensuring compliance with European Union regulations.
Prepare and Submit Documentation for CE Marking: Develop and manage technical files and dossiers for submission to Notified Bodies. Ensure all documentation meets the EU requirements for medical devices.
Maintain Documentation: Regularly update documents to align with changes in legislation and standards, and incorporate product modifications.
Liaise with Notified Bodies: Coordinate with certification organizations for the compliance and certification processes.
Monitor Regulatory Developments: Stay updated with legislative and standard changes related to medical devices in the EU.
Develop and Update Internal Procedures: Create and revise processes and procedures to ensure ongoing compliance with regulatory requirements.
Internal Training and Consultation: Provide guidance and training to other departments on CE compliance matters.
Risk Management: Analyze and manage risks associated with regulatory compliance and certification processes.
Support Audits and Inspections: Prepare for and assist with external audits and inspections.
Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Regulatory Affairs).
Proven experience in regulatory affairs, specifically in medical devices and CE marking.
In-depth knowledge of EU medical device regulations.
Strong project management skills and attention to detail.
Excellent communication and interpersonal skills.
Ability to work in multidisciplinary teams.
What We Offer:
A dynamic and international work environment.
Competitive salary and benefits.
Opportunities for professional growth and development.
Qualified candidates are invited to submit their resume and cover letter, detailing their experience and qualifications for this role.