Regulatory Compliance Specialist
3 weeks ago
Regulatory Affairs Manager Job Description
About the Role
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Omega Resource Group. As a key member of our team, you will be responsible for ensuring business compliance with regulatory requirements and quality standards.
Key Responsibilities
- Ensure business compliance with regulatory requirements and quality standards.
- Maintain up-to-date knowledge on domestic and international regulatory requirements.
- Communicate effectively with management and project teams.
- Support the maintenance of the Quality Management System in accordance with relevant regulatory/statutory requirements.
- Develop and prepare technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.
- Provide advisory notices as required, in accordance with MDD, MDR, and FDA regulatory requirements.
- Proven experience within regulatory affairs with an extensive amount being in a managerial position.
- Medical Device experience is essential.
- Lead Auditor training.
What We Offer
We offer a competitive package including 25 days annual leave + Bank Holidays, Private Health Care Options, Employee Assistance Programmes, and a Competitive Pension Scheme.
Requirements
Our ideal candidate will have a background in regulatory affairs with experience in a managerial position. Medical Device experience is essential. Lead Auditor training is also required.
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