- 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.
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.