Job Description:

Designation:     Regulatory Head

Experience:       Minimum 12 years

Reports To:        Manufacturing Head

Location:            Dehradun

Key Responsibilities:

General Accountability:

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

Responsibilities:

• Lead transition from MDD to EU MDR
• Provide project leadership to transition all regulatory technical files to MDR compliant Technical Documents for submission to the Notified Body within timeline.
• Write, analyze, and edit technical documents to support country- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
• Identify information needs; ensure information flows to appropriate functional areas, support document reviews/ approvals.
• Identify project risks and escalate as appropriate.
• Maintain regulatory files. Maintain and update regulatory authorizations, such as 510(k)s, and CE dossiers for EU etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other 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.
• Assess device related incidents/complaints for medical device 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 input to minimize potential for findings 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.

Requisites:

• 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 managers and department heads on regulations and polices that require compliance.
• Knowledge of Drug pharmacology, kinetics, release, 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.