- Ensure regulatory compliance for medical devices and equipment by preparing and submitting required documents to relevant authorities.
- Develop and maintain accurate records of regulatory submissions, including product approvals and recalls.
- Collaborate with cross-functional teams to identify potential risks and develop strategies to mitigate them.
- Provide guidance on regulatory requirements to internal stakeholders, ensuring adherence to company policies.
Job Requirements :
- 5-8 years of experience in Regulatory Affairs or related field (Medical Devices & Equipment).
- Solid understanding of regulatory compliance, regulations, and guidelines governing the industry.
- Proficiency in preparing complex regulatory documentation (e.g., applications, reports) according to specific formats.