Regulatory Affairs Specialist (Temporary-Ankara)

Nitelikler/Qualifications, İş Tanımı/Job Description:

 

We are looking for a “Regulatory Affairs Specialist (Temporary-Ankara)” for our multinational client operating in medical sector.

Bachelor’s Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations,
Strong analytical skills,
Ability to work in a team environment with minimal supervision on projects and activities,
Ability to prioritize, plan & evaluate deliverables,
Knowledge & experience conducting scientific, regulatory, legal, or business research,
Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner.


JOB DESCRIPTION

File and maintain regulatory deliverables,
Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies,
Support regulatory inspections as required,
Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes.