Hello, Hope you are doing well, We have the below requirement open. Please send me your candidates updated Resume to *[email protected] <[email protected]>*
*Role : Regulatory engineer / Regulatory Specialist (Medical Devices)* *Location : Remote* *Job Roles / Responsibilities: * • Regulatory knowledge (European Medical device directive and Medical device Regulation) • Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820) • Regulatory experience in Medcial Device Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan • Project Management experience • Expereince in Regulatory assessment of Engineering/ Design change execution • Very good written and oral communication in English. • Ease for reading/creating/modifying documents. • Able to work with minimal supervision. Self-motivated team player. *Must to have:*Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH Regulatory Submissions / Global Regulatory Submissions/ International Submission Medical Device Registration/ Re-registration/ Regulatory licenses renewals Change submission, notifications • Assists the Regulatory Affairs Manager for ensuring compliance with the requirements set by the EU Medical Device Regulation and other regulatory bodies for Medical devices registration across different geographies • Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan • Prepare and review the documentation required for Change submission, Notification , Re-registration of Medical devices • Provide guidance to the offshore team in the preparation of documents for change submission, notification, re-registration packages of Medical Devices for regulatory agencies submission. • Understands existing technical files / design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and prepare the Country specific STEDs. • Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs • Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team. • Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders. • Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information. • Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities. • Maintains information systems (electronic and paper) for regulatory information and reports. • Oversee and ensure maintenance of regulatory licenses renewals on timely manner • Clearly conveys information to peers, supervisors and other stakeholders • Supports the development of internal RA systems and procedures. • Maintains SOPs related to RA activity and suggests update of the QMS • Review of deliverables as Regulatory expert ( STED and Country specific documentation) *Thanks & Regards* *Mohd Azhar Uddin* *Tel: 703-831-8282 Ext. 2526 / (M) (315) 543-4232* *Email: [email protected] <[email protected]> * -- You received this message because you are subscribed to the Google Groups "project managment" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web visit https://groups.google.com/d/msgid/project-managment/CAFp5OXg7qu1LKcQ2WMEfMeuQqNtsw4%2Bd7Fmdgwg%3DkAzXpPNHKA%40mail.gmail.com.
