Regulatory Affairs Professional
The ideal candidate will have a degree level qualification in Engineering, Science, QA, or related field and at least five years' experience as a senior regulatory professional in the medical device industry. Key responsibilities include implementing post-market activities under Post Market Regulatory Reporting and change assessment, approving Vigilance/MDR reporting, supporting and leading Regulatory Post Market System improvements, and managing RA activities for Design Changes and Supplier-related changes.
You will work closely with the Senior Regulatory Affairs Manager and other team members to ensure compliance with relevant Quality System procedures and Work Instructions. This role is an excellent opportunity to add real value to the future success of the company.
We are seeking a highly skilled Regulatory Affairs Specialist who can leverage their expertise to drive business growth and improve product quality. If you have a strong background in regulatory affairs and a passion for delivering high-quality results, we encourage you to apply for this challenging and rewarding position.
Key Responsibilities:
* Implementing post-market activities under Post Market Regulatory Reporting and change assessment
* Approving Vigilance/MDR reporting
* Supporting and leading Regulatory Post Market System improvements
* Managing RA activities for Design Changes and Supplier-related changes
Requirements:
A degree level qualification in Engineering, Science, QA, or related field and at least five years' experience as a senior regulatory professional in the medical device industry. Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
What We Offer:
This is a fantastic opportunity to join a dynamic and growing company and contribute to the development of innovative medical devices. As a member of our team, you will have the chance to work on challenging projects, develop your skills, and advance your career in a supportive and collaborative environment.