Regulatory Affairs Manager North Africa

AH group - الجزائر - Algiers


JOB DESCRIPTION:

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


- Responsible for obtaining and maintenance of appropriate licenses and registration for all Abbott Diagnostics and Abbott Molecular products intended for the respective regulated countries.


- Coordinate registration and re-registration with distributor countries in North Africa


- Represent the company as an active member in trade associations as applicable and during discussion with authorities


- Assessment of product changes, to ensure compliance with regulatory requirements



- Identify new or changed regulations communicated through authorities, trade associations or other means and media


- Report regulation changes and new requirements to country management and area regulatory affairs manager


- Communication of Field Safety Corrective Actions (FSCA), Recalls, Product Corrections and Medical Device Incidents to Authorities, as applicable


- Provides leadership in developing strategies to comply with regulations in order to achieve early market entry and cost effective operation of the business while maintaining regulatory compliance


- Ensure compliance with Advertisement and Promotional requirements in North Africa and other countries under ADD North Africa responsibility, if applicable



JOB FAMILY:Regulatory Operations


DIVISION:ADD Diagnostics


LOCATION:Algeria > Algiers : Lotissement Said Ben Haddadi


ADDITIONAL LOCATIONS:


WORK SHIFT:Standard


TRAVEL:Yes, 10 % of the Time


MEDICAL SURVEILLANCE:Not Applicable


SIGNIFICANT WORK ACTIVITIES:Not Applicable




تاريخ النشر: ٢٥ أكتوبر ٢٠٢١
الناشر: Bayt
تاريخ النشر: ٢٥ أكتوبر ٢٠٢١
الناشر: Bayt