Regulatory Engineer

Career Opportunity:
Job Title: Regulatory Engineer

About CodeForce 360
Making a career choice is amongst the most critical choices one can make, and it's important for the choice to be calculated with factors such as a company's run of success since its inception and more. But, when you come across a company that has reputation proven with nothing but an illustrious run of success since the day it began, you don't need to think of anything else. That's precisely what some of our employees and prospective employees think when they came across CodeForce 360.

Position Overview

Regulatory Engineer

Requirements:

• 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 Clients.
• 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)

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
• STED Preparation
• Regulatory Approbation
• EU MDD/MDR Tech documentation Summary
• Notified Body
• CE Technical File / EU Technical File / Design Dossier

Adds Value:

• RAC Certification: Medical Devices
• FDA 510(K), PMA Submission
• Collateral/Product specific IEC Standards Knowledge
• Support EU MDR Transition activities
• EU MDR Gap Analysis

Education:

Master of science in Biomedical Engineering/ Bioengineering discipline

Required Skillset

• 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 Medical Device Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Project Management experience
• Experience 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.

How to Apply

Job ID: JPC - 45763

For more information, please contact below:

Vipul Gurjar

Qualified individuals will be contacted for an interview.

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