Job Details
Experience Needed:
Career Level:
Education Level:
Gender:
Salary:
Job Categories:
Skills And Tools:
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
- 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.
