Remote - Regulatory engineer / Regulatory Specialist (Medical Devices)

[azhar uddin]

Hello,
Hope you are doing well,

We have the below requirement open. Please send me your candidates updated Resume to

m.a...@canopyone.com

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: m.a...@canopyone.com