• 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.

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