Medical Device Vigilance Specialist

Why This Role Matters
The Vigilance Specialist plays a critical role in ensuring patient safety and regulatory compliance by managing complaints, monitoring product incidents, and supporting post-market surveillance activities. This role ensures that all vigilance processes meet regulatory standards while helping the organization maintain high-quality medical device safety across global markets.

Job Description
The Vigilance Specialist will be responsible for end-to-end complaint and incident management for products placed on the market. The role involves evaluating reported events, preparing regulatory submissions, supporting product risk management activities, and coordinating with global stakeholders to ensure compliance with vigilance regulations and internal SOPs.

Key Features of the Role
• Receive, record, evaluate, investigate, and process complaints related to marketed products.
• Manage complaint case flow to ensure timely processing and compliance with regulatory deadlines.
• Perform medical and technical evaluation of reported product incidents.
• Maintain complete and accurate documentation in vigilance and complaint management systems.
• Prepare vigilance data to support product risk management activities.
• Generate vigilance reports to support global product registrations and renewals.
• Prepare vigilance-related data for Clinical Evaluation Reports, Technical Files, and regulatory documentation.
• Submit medical device incident reports to regulatory authorities worldwide.
• Ensure compliance with internal SOPs and external regulatory requirements.
• Support training and awareness of vigilance processes for internal teams and distribution partners.
• Assist in developing and updating SOPs, work instructions, and training materials related to vigilance.
• Participate in internal and external audits and regulatory inspections.
• Act as a liaison between regional teams, distributors, and global headquarters.
• Support the Vigilance Manager in tracking regulatory and legislative updates.

Responsibilities
• Manage complaint intake, investigation, and documentation processes.
• Conduct technical and medical assessments of reported events.
• Prepare and submit regulatory vigilance reports to health authorities.
• Support product risk management and post-market surveillance activities.
• Maintain regulatory compliance across global markets.
• Collaborate with cross-functional teams to ensure effective vigilance processes.

Required Qualifications
• Bachelor’s degree in Life Sciences, Clinical Sciences, Engineering, or related field.
• Postgraduate qualification in Pharmacovigilance, Medical Device Vigilance, or Regulatory Affairs is an advantage.
• 3–6 years of experience in vigilance, pharmacovigilance, or medical device post-market surveillance.

Educational Requirements
• Bachelor’s degree in life sciences, clinical sciences, engineering, or related field.
• Additional specialization in pharmacovigilance or regulatory affairs preferred.

Experience and Skills
• Knowledge of medical device vigilance systems and regulatory requirements.
• Experience handling global markets and multiple regulatory authorities.
• Strong analytical skills for evaluating complaints and incidents.
• Ability to prepare regulatory documentation and vigilance reports.
• Excellent communication and collaboration skills for working with global teams.
• Experience with post-market surveillance and risk management processes.
• Prior experience with ophthalmic products is highly preferred.

Salary Insights
• Salary details are not specified and will be discussed during the recruitment process.

Company Overview
Rayner is a global leader in ophthalmic medical devices, dedicated to improving vision and enhancing the quality of life for millions of people worldwide through innovative eye care solutions.

FAQs
• Where is the job location?
Ahmedabad, India.

• What type of role is this?
Permanent full-time position in Regulatory Affairs/Vigilance.

• What experience is required?
3–6 years in vigilance, pharmacovigilance, or medical device post-market surveillance.

• Is global collaboration involved?
Yes, the role involves coordination with global teams and regulatory authorities.

Application Tips
• Highlight experience in pharmacovigilance, medical device vigilance, or post-market surveillance.
• Demonstrate knowledge of regulatory reporting and global compliance requirements.
• Emphasize your ability to handle complaint investigations and incident evaluations.
• Showcase collaboration experience with cross-functional and international teams.
• Include examples of regulatory submissions, vigilance reporting, or audit participation.