Sr Regulatory Operation Specialist

Overview

Support international registrations, licensing, product change notices, label change requests and regulatory databases for medical devices, working with regulatory and cross-functional teams.

What you'll do

• Upload, verify and validate new regulatory information in the RIM database.
• Maintain registration and licensing information.
• Create submission packages for international registrations.
• Initiate renewals with countries.
• Initiate product change notices per input from BU Project RA Specialist.
• Establish and maintain dashboards on product change notices, including updates to RIMSYS, the PCN tracker master sheet and the AOP list.
• Initiate local label requests through change requests.
• Monitor the status of label change requests through implementation and ensure timely label release by R&D (every 6-8 weeks).
• Publish status to stakeholders on weekly/monthly maintenance and reporting dashboards.
• Produce dashboards and reporting for international registrations, labelling and gap assessments.
• Establish registrations and device listing for the USA, Canada and EU.
• Maintain a repository of Declarations of Conformity, LTFs, 510(k)s and TD documentation.
• Maintain EUDAMED, GUDID and other regulator databases as required for the region using ReedTech software.
• Gather information from subject-matter experts and develop, organize and write documentation for submissions.
• Work with development and support leads to identify documentation repositories and determine solutions for data compilation and centralized storage.
• Research, create and maintain information architecture templates that adhere to organizational and legal standards.
• Develop content in alternative media forms with a consistent voice across documentation.
• Support the coordination and preparation of regulatory submissions for product licensing, managing files for device updates and related control processes.
• Keep abreast of regulatory procedures and changes and participate in process improvement activities.

What you'll need

• Degree in engineering or a related discipline.
• 7-10 years of professional experience in medical device regulatory affairs.
• Strong proven knowledge and experience in international registrations.
• Excellent data analytical skills and expert user of Office 365 tools including Power BI and Automate.
• Good documentation practices and ability to work independently to drive initiatives that improve the way of working.
• First-time-right attitude.
• AI White Belt Ninja certification.

Nice to have

• Experience with systems for quality management, product development and follow-up of procedures.
• Bachelor's degree or vocational education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• 10 years of professional experience in medical device regulatory affairs.
• RAPS RAC certification.

Details

• Location: Bangalore.
• Office-based teams work in person at least 3 days per week.