Regulatory Affairs Specialist

Surgitech - Mokattam, Cairo

82
Applicants for
2 open positions
22
Seen
10
Shortlisted
6
Rejected
Experience Needed:
1 to 4 years
Career Level:
Entry Level
Job Type:
Full Time
Salary:
Negotiable, Medical & Social Insurance
Vacancies:
2 open positions
About the Job
  • Ensure submission and approval of Medical Devices registration files to the MOH for new launches, and registration renewal applications to keep licenses valid.
  • Supervising the regulatory team in Egypt this includes:
  1. Training of new members, job know how & responsibilities.
  2. To put the annual registration submission plan with priorities based on the business plan and compliance obligations, which include clear objectives, target completion dates, with regular follow up with Egypt regulatory team on progress of agreed plan.
  3. Develop PDP (Personal Development Plan) for Regulatory Team in Egypt.
  4. Answering franchise/regional regulatory & QA requests and queries within the required time frame.
  • Maintain a strong & strategic partnerships and credibility with key regulatory authorities in the MOH.
  • Provide a better understanding on the international guidelines for MDs to local authorities that help to accelerate and simplify the registration process of MDs.
  • Assigned Local Safety Officer (LSO) handling products recalls and complaints communications with MOH Vigilance Department (MDSD) to be in compliance with MOH regulations.
Job Requirements
  • 1 to 4 years of experience.
  • Excellent communication skills.
  • Excellent presentation skills.
  • Ability to work under pressure.
  • Multi Task person.
About this Company

With close to 20 years' experience in providing quality healthcare solutions in Egypt, UAE, Sudan, Lybia ...Shaarani Group now operates out of 5 countries with affiliates in the USA, Japan, France, Korea & Germany. Our healthcare products and services range from basic... (More)

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