Are you a proven Regulatory Affairs professional with a passion for cutting-edge technology and its impact on healthcare? Are you ready to make a profound impact on the lives of millions by transforming wound care treatments?

Cure Talent is delighted to be partnering with an exciting Medical Device Manufacturer specialising in Wound Care products, to find an exceptional Regulatory Affairs Manager. Join them in driving technological advancements in wound care and shaping the future of their organisation.

As the new Regulatory Affairs Manager, you will be responsible for developing Regulatory Strategies, MDR compliance, Product Changes and New Product Submissions. Working in close collaboration with the Head of Quality you will foster a culture of Quality and Compliance across the business.

Key Responsibilities:

• Create and maintain the Regulatory Strategy for New Product Launches.
• Regulatory Submissions for the UK and EU (and other markets as defined by the Regulatory Strategy).
• Working with the Head of Quality, maintain the company’s Quality Management System and foster a culture of Quality & Compliance.
• Implementation & Compliance with Regulatory Standards and Systems
• Stay abreast of changes in the regulatory landscape ensuring they are communicated and implemented as appropriate.
• Ensure the Clinical and New Product Development (NPD) Teams have the appropriate resources to implement and maintain the effectiveness of the QMS and meet regulatory and customer requirements.
• Together with the Head of Quality, ensure Design Inputs have been created to include appropriate regulatory requirements.

Qualifications:

• BSc/MSc in an engineering, medical or sciences background or related field, or equivalent relevant experience required.
• Proven experience of Leadership in Regulatory Affairs in the Medical Devices industry
• Working knowledge of global Quality and Regulatory requirements for the design, development, manufacture, and marketing of Medical Devices.
• Proven UK & EU Technical File Submission Experience
• Proven and detailed working knowledge of MDR Requirements
• Certified ISO 13485 Lead Auditor

If you have the required skills and experience and want to join an innovative, growing company, please get in touch with Kris Holmes or apply today!