Job Details
Skills And Tools:
Job Description
Job Description
• Prepare and submit regulatory documentation for product approvals, renewals, and variations to EDA
• Maintain regulatory submissions database and track status.
• Ensure continuous compliance with relevant regulatory requirements and standards (e.g., ISO 13485, MDR, IVDR).
• Monitor changes in regulatory requirements and communicate implications to the relevant teams.
• Manage product registration activities for new and existing products.
• Maintain up-to-date records of all product registrations and licenses.
• Maintain and organize regulatory documentation and files.
• Provide regulatory guidance to cross-functional teams during product development and lifecycle management.
• Participate in project teams to ensure regulatory compliance from concept through commercialization.
• Support regulatory inspections and audits.
• Prepare and manage responses to regulatory inquiries and inspection findings.
• Prepare and submit pharmacovigilance documentation to regulatory authorities.
• Ensure timely follow-up on all pharmacovigilance-related queries and requirements.
• Maintain accurate records of all pharmacovigilance submissions and communications.
Job Requirements
Job Requirements
• Bachelor’s degree in a Medical field (e.g., Science, Vet, Pharmacist).
• Minimum of [2] years of experience in regulatory affairs within the medical device industry.
• Knowledge of global regulatory requirements and standards (e.g., FDA, FSC, CE, ISO 13485).
• Knowledge of Local regulatory requirements and standards (e.g., EDA and Medevice).
Excellent written and verbal communication skills.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in Microsoft Office Suite.
• Excellent written and verbal English skills.
