Job Summary
A Senior Regulatory Officer is required to drive quality culture and champion compliance to global regulations, working closely with the regulatory manager on new IVDR regulations.
Key Responsibilities
* Drive quality culture in accordance with quality policies and guidelines.
* Champion compliance to applicable global regulations and standards.
* Collaborate with the regulatory manager on new IVDR regulations.
* Support implementation of company regulatory strategies and provide guidance and expertise.
* Compile and communicate regulatory requirements and gap analysis assessments to multi-functional groups.
* Review and approve project documentation, ensuring updates to Technical Files and international registrations are conducted appropriately.
Requirements
* Bachelor's degree in molecular biology or related discipline and/or 5 years' experience in a regulatory role.
* Minimum 2 years' experience in a Medical Device or In Vitro Diagnostic Company.
* Working knowledge of ISO 13485 and ISO 14971 standards.
* Excellent communication and interpersonal skills.