Company Overview
Omega Resource Group specializes in opportunities at all levels within various sectors, including Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction, and Manufacturing.
Job Description
The successful candidate will be responsible for ensuring business compliance with regulations and quality standards in the medical device industry. This includes maintaining up-to-date knowledge on domestic and international regulatory requirements and communicating effectively with management and project teams.
Key Responsibilities:
1. Maintaining the Quality Management System in accordance with relevant regulatory/statutory requirements.
2. Issuing advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements.
3. Developing, preparing, and maintaining high-quality technical files, design dossiers, and necessary applications for regulatory submissions and approvals.
Requirements and Qualifications:
* Proven experience within regulatory affairs, preferably in a managerial position.
* Extensive medical device experience is essential.
* Lead Auditor training is desired.
* MDR experience is highly valued.
Benefits Package:
* Comprehensive benefits package, including competitive salary, annual leave, and private health care options.
* Employee Assistance Programs to support overall well-being.
* Opportunities for career growth and professional development.