Director Of Regulatory Affairs

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 are delighted to be partnering with Matoke Holdings, a groundbreaking development stage wound care company, to find an exceptional Director of Regulatory Affairs & Quality Assurance. Join them in driving technological advancements in wound care and shaping the future of their organisation.

This role is able to be tailored to align with the unique needs and situation of the right candidate.

As the new Director of Regulatory Affairs & Quality Assurance, you will play a pivotal role in developing the Regulatory Strategy for the market launch of innovative medical devices that improve wound healing and patient outcomes. This is an incredible opportunity to lead the Regulatory & Quality functions of a rapidly growing company, creating and implementing the Regulatory Strategy for new market & product launches.

Key Responsibilities:

• Create and maintain the Regulatory Strategy for market launch.
• Plan and co-ordinate regulatory submissions ensuring they are prepared in line with regulatory requirements.
• Working with the Quality Management Lead, maintain the company’s Quality Management System
• Stay abreast of changes in the regulatory landscape ensuring they are communicated and implemented as appropriate.
• Identify, communicate and implement Regulatory Requirements for US sales.
• 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 Quality Management Lead, 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 and Quality Management in the Medical Devices industry (preferably Antimicrobials / Wound Care) required.
• Working knowledge of global Quality and Regulatory requirements for the design, development, manufacture, and marketing of Wound Care devices.
• Previous experience in hosting FDA inspections/regulatory authority audits.
• Analytical and statistical analysis skills.

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!