Regulatory Affairs function and systems. collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for registrations globally. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion.
Responsibilities:
• Assistance on the development of regulatory strategies for new product development and product changes.
• Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements.
• Assists with the preparation, review, and approval of department SOP’s.
• Support responses to regulatory authorities’ queries within defined deadlines
• Manage & maintain Regulatory owned technical documentation.
• Manage regulatory activities and act as the primary contact for specific markets.
• May review labeling and promotional material for compliance with local regulations.
• Maintain annual licenses, registration renewals and listings with various health authorities.
• Supports the monitoring and assessment of RA intelligence (regulations, laws, guidance documents, standards)
• Provides required information (e.g., clinical data) in support of product reimbursement requests.
• Participate on project teams including continuous improvement projects/tasks and partner cross-functionally, as needed.
• Apply appropriate structured problem-solving tools and techniques to given issues such as Fishbone, 3C, A3 etc.
• Support the maintenance and continuous improvement of the Regulatory Information Systems and processes such as MAP, CPLRs, RACR, UDI etc.
• Additional responsibilities as identified to execute the role as described
• US FDA or EUMDR submissions experience is must
Essential Functions of the Role**:
• Sitting at desk
Work Experience Requirements
• Number of Overall Years Necessary: 2-5
• 2-5 years of regulatory experience
Education Requirements
Bachelor’s Degree in science, engineering, or medical field
Specialized Skills/Technical Knowledge:
• Strong written and verbal communication skills
• Knowledge of regulations and design controls
• Developing negotiation skills and problem-solving skills
• Ability to work closely with people at multiple levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to manage or lead multiple small projects and deadlines.
• Ability to identify compliance risks and escalate when necessary.
• Knowledge and understanding of US FDA, EU MDR and other country Medical Device regulations is desired.
• Experience with ISO13485 standard and its requirements is desired

Location - Gurugram

Mode - Hybrid