Crop Picture
NOTE: Do not upload any image that violates our Picture Policy. Doing so will result in the removal of the concerned image without prior notification.
概要
i am Mahrukh Ali, graduated from university of Karachi in Pharm-D.
my motivation and hard work lead me to the opportunity of Manager Regulatory Affairs in one of the well known Medical Device and diagnostic importers i.e. Hospicare Systems sister concern of Muslim Trading Agencies.
further job responsibilities are under job section in detail.
项目
工作经历
Manager Regulatory Affairs, AQP, ISO 9001 Lead Auditor
• Working as “Manager Regulatory Affairs” at Hospicare Systems from March 2018 till date.
o Registration Dossiers
Coordinate with international principals and prepare document packages for regulatory
submissions and ensure the timely and accurate filing.
Follow-up of submission of registration dossier.
Keeping records of registered dossier at DRAP.
o Compliance
Ensures compliance with the applicable local and company requirements.
Develops proficiency in any applicable regulatory requirement that applies to our products and
ensures new or changed requirements are communicated within the organization.
Coordinate, monitor and execute of Regulatory PMS activities including Vigilance reporting and
Field Action execution.
Compliance of ISO 9001:2015, ISO 13485:2016, MDR 2017 & GDPMD.
o QMS
Working as management representative for QMS.
Ensure quality management systems as per SOPs, WI etc.
Perform internal audits for QMS.
Conduct management review meetings for QMS.
o MR/QMS internal Auditor
awareness of ISO
Ensure implementation of departmental SOPs, WI.
Conduct audits biannually.
Maintain records of audits.
regulatory affairs officer
dealing all the regulatory compliances of pharmaceutical and medical devices.
providing services like
1. dossier prep
2. licensing
3. import/export documentation
4. medical device registration and license
