Offers “Abbott”

13 days agoAbbott

Regulatory Affairs Specialist (1 year contractor)

  • Ümraniye, Türkiye
  • Teaching

Job description

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

As Abbott Turkey, we help people live healthier and better lifes through our Established Pharmaceuticals, Diagnostics, Nutrition, and Medical Devices business for more than years. We have approximately 750 employees working nationwide in different areas.

Abbott Diagnostics Division is looking for a Regulatory Affairs Specialist (1 year contractor) reporting to Regulatory Affairs Manager

Job Description

· 
Responsible for the implementation of regulatory compliance as required by international and local regulations and Abbott policies and procedures

· 
Responsible for supporting and maintenance of regulatory approval of all ADD and AM products intended for distribution in regulated countries of SEE & I

· 
Submit documentation for registration and re-registration with distributor countries.

· 
Support discussions with authorities in order to better understand regulations, build relationship and clarify issues

· 
Assess product changes, to ensure compliance with regulatory requirements

· 
Monitor local regulations, e.g. language requirements and medical event reporting

· 
Support and execute strategies to comply with regulations in order to achieve early market entry and cost-effective operation of the business while maintaining regulatory compliance

· 
Provide support for Adverse Event and Field Action reporting as necessary

· 
Maintain internal and divisional regulatory databases (IRIS)

· 
Provide support during audits as necessary

· 
Attend at least one RA-related developmental course (Abbott or Non-Abbott) as part of overall development plan

Your Qualification

· 
Bachelor’s degree in Life Sciences or Engineering

· 
Preferably 1-3 years of experience in the medical device / IVD industry preferably in the area of Regulatory Affairs or Quality Assurance

· 
Knowledge of PC-based application.

· 
Technical skills related to IVD or Medical Devices

· 
Fluent in English (written and spoken)

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

Discover why candidates choose a career with Abbott in Turkey.

AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADD Diagnostics

        

LOCATION:

Turkey > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd Umraniye

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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