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.
- 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
Skills / Experience: Required skills:
Technical Bachelor’s degree in a science discipline with Regulatory knowledge (European Medical device directive and Medical device Regulation, Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820)