Job Description:

General Accountability:

Responsible for regulatory affairs activities to assist in regulatory submission annual reports, registration and listings. Assure compliance with applicable medical devices regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.

Key Responsibilities:

• Lead transition from MDD to EU MDR.
• Provide projects leadership to transition all regulatory technical files to MDR compliant Technical Documents for submission to the Notified Body within timeline.
• Write, analyses, and edit technical documents to support country- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents including investigational device submission requirements when documents are needed for regulatory submission.
• Identify information needs ensure information flows to appropriate functional areas, support document reviews/ approvals CE dossier for EU etc. Assure that appropriate maintenance of registrations occurs including renewals, device listing, site registrations, supplements for changes and annual reports. Support approval in order regions as required.
• Assist in preparing response to regulatory authority’s questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Access device related incidents/complaints for medical devices reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
• Support external regulatory agency audits, providing regulatory inputs to minimize potential for finding of non-compliance.
• Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required.
• Other duties as assigned.

Requisite Skills:

• Experience with Class III medical devices in Vascular Intervention will be added advantage.
• Extensive knowledge of EUMDR and applicable government regulations. Understanding of Technical master files and ability to make necessary modifications as per EU MDR.
• Ability to inform and educate manger and department heads on regulations and policies that require compliance.
• Knowledge of Drug pharmacology, kinetics, stability studies, microbiology etc.
• Regulations pertaining to DCGI.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Excellent strategic planning skills.
• Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams.
• Can work independently and demonstrates initiative and resourcefulness.
• Drives to meet goals.
• Prolonged periods sitting at a desk and working on a computer.

About the company:

Incorporated in 2010 with an objective to create path breaking technologies for providing better healthcare solutions to the Physicians & Patients for improving Clinical Outcomes for various Cardiac Disorders. Has strategic partnership with Client GmbH, Germany for creating world class products with highest standard of quality and clinical significance.