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