The ideal candidate will be responsible for group-level Regulatory Affairs.

JD

- Plan global regulatory strategy and prepare regulatory submissions for Notified Bodies, CDSCO, and Competent Authorities, as required.
- Handling CE Marking and Technical Documentation completely for class IIa and Class IIb devices.
- Interact directly with Notified Bodies and CDSCO to facilitate the timely assessment of regulatory submissions and timely response to Regulatory bodies' questions.
- Develops and implements global Regulatory strategies for recent product development, ensuring that pre-market Regulatory requirements are captured in global regulatory strategies and development plans while balancing business objectives.
- Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to the Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by notified bodies when necessary.
- Developing and implementation of the SOP.
- Review and approve quality system documents to determine compliance with regulatory regulations and standards.
- Prepare failure mode effect analysis (FMEA) sheets and perform risk assessment.
- Independently launch and manage recall(s), including communications to regulatory agencies and customers
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.




- Manage relationships with key stakeholders in technical Operations and Quality and across Regulatory Affairs to provide regulatory support in achieving their strategic objectives.
- Ensuring that checking and auditing procedures are carried out.
- Conduct awareness programs on regulatory changes and quality management system requirements.
- Assist in reviewing policies and procedures & serve as Regulatory Affairs representative on facility/site.
- Conducting audit and management review meetings for the excellent quality internal management system.
- Assisting management in the monitoring of state and global regulatory and legislative development to identify issues affecting the company’s operations and plans.
- Post-market surveillance activities.
- Identify opportunities to implement process and procedural improvements to drive efficiency to the organization.
- Maintain up-to-date knowledge and understanding of applicable medical device regulatory requirements and standards, including but not limited to, ISO13485, MDSAP, and EU MDR.

Educational & Work Experience :

- Master’s/ degree in Engineering, Life Sciences, Pharmacy, or related field.
- 8 + years of experience in Regulatory Affairs in Medical Devices OR Pharma, preferably from Medical Devices
- Experience interacting directly with EU Notify Bodies, CDSCO, including audits and inspections.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Experience with combination products is preferred.

📌 Assistant Manager - Regulatory Affairs (Davanagere)
🏢 Shah Eye Care
📍 Davanagere