regulatory affairs specialist.

Responsible for coordination and implementation of RA activities in line with international regulations, policies and procedures.
Follow-up of developments and changes in the local international standartds, regulatory rules, legislations and guidelines.
Plays active role in implementation of Regulations/Guidance Documents throughout the functions and participate in standards assessment process with responsible parties at site.
Plays an active role in Notified Body, FDA and other authorities audits and represents regulatory topics.
Plays role in resolution of regulatory relevant Quality Plans, CAPA, nonconformity or other QMS activities.
Plays an active role in managing and maintaining of Regulatory Holds and concessions.
Play an active role in Engineering and R&D activities.
Evaluate the effects of change control activities from regulatory perspective and implement required regulatory steps on a timely manner.
Contribute to all the product and quality certification related processes and all internal activities (e.g. CHMM, new product phases/launches) from RA perspective.
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