Global Regulatory Affairs Director
3 days ago
We are currently recruiting for a Regulatory Affairs Manager to lead our team's efforts in maintaining regulatory compliance and ensuring market access for medical devices internationally.
This is an exciting opportunity for a highly motivated and experienced professional to join our dynamic team and contribute to the company's overall goal of maintaining quality standards and business compliance.
The ideal candidate will have a strong background in medical devices, quality management systems, and regulatory affairs, with excellent communication and leadership skills.
Key Responsibilities:
- Maintaining up-to-date knowledge of domestic and international regulatory requirements and communicating effectively with stakeholders.
- Supporting the maintenance of the Quality Management System in accordance with relevant regulations.
- Developing and preparing high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.
- Issuing advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements.
Requirements:
- Proven experience in regulatory affairs, preferably in a managerial position.
- Essential medical device experience, with Lead Auditor training and MDR experience desirable.
Benefits:
- 25 days annual leave + Bank Holidays.
- Private Health Care Options.
- Employee Assistance Programmes.
- Competitive Pension Scheme.
Estimated Salary: £65,000 - £85,000 per annum, depending on experience.
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