Mona Hari

Strongly reliable and focused Regulatory Affairs Specialist
with great depth and breadth of experience in medical
device review and evaluation. Superb multitasker able to
handle multiple projects efficiently and accurately. Effective
independent worker as well as excellent coordinator with
other members of a regulatory affairs team.

Responsible for document management system such as SOP/ Work
Instruction/ Change Control Request/ CAPA are documented, reviewed and
analyzed to ensure QMS is implemented and maintained.
External Quality Audit coordinator and conduct internal audit according to
ISO 13485
Coordinated audit preparation for TUV Rheinland audit on ISO 13485 and
act as Deputy Quality Management Representative during audit.
Plan, implement and monitor the finish good's quality to ensure customer
standard and requirements are meet and responsible for final release of
shipment.
Managed work force arrangements within the section.
Handling and managing customer complaint through the Corrective action
and Preventive Action (CAPA) system.
Monitoring and analyzing quality performance for improvements.
Coordinated the third party inspection and reported for any abnormalities.
Liaised with marketing, planning , packing and shipping on delivery.
Liaised with production, packing, warehouse on any quality issues of incoming,
in-process and finished goods.
To ensure products manufactured or distributed comply with the required
medical device regulations (eg. FDA, MDR, MDD, MDA, PPE).
To ensure the appropriate licensing and legal compliance of products in
order to control the safety and efficacy of products.
To manage and facilitate all submission and/or renewal of license, product
listing and registration/ certification (e.g 510K, CE marking, TGA, PPE
certificate, product testing).
Liaised with regulatory authorities and designated agents.
Reviewed and keep up to date with changes in regulatory legislation,
guidance and etc.
Assures the ongoing compliance by reviewing company practices and
provide advice on changes to systems ( eg. Technical File, Risk Management
File).
Outlining requirements for labelling, storage and packaging.
Keep abreast with internal and external gloves industry regulatory news and
updates, guidelines, standards etc

Universiti Selangor
Masters in Biotechnology | Jul 2019 -
November 2021
Research Mode
Title: Optimization of Culture Conditions for
Improved Biodecolourization of Methylene
Blue by Rhodococcus strain UCC 0003