Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a strong international presence and continued investment into next-generation technologies, the business is continuing to expand its regulatory capability across high-profile product programmes.
We have an opportunity for a Principal Regulatory Affairs Specialist to join the organisation and support the development and approval of a brand new medical device programme under MDR 2017/745. Working as part of a highly experienced global Regulatory Affairs function, this role will play a key part in helping bring an innovative new product to market across Europe.
The position is centred around technical Regulatory Affairs ownership and cross-functional project leadership rather than people management. You will work closely with R&D, Clinical and global Regulatory teams throughout the product development lifecycle, supporting regulatory activities from early-stage development through to submission and approval. Alongside this, you will contribute to the regulatory strategy for the programme, helping define approval pathways, manage regulatory risk and support interactions with Notified Bodies and Competent Authorities.
To be successful as the new Principal Regulatory Affairs Specialist, you will have proven Regulatory Affairs experience within the Medical Device sector alongside strong working knowledge of MDR 2017/745. You will have experience supporting new product development activities, contributing to regulatory submissions and operating within cross-functional product development environments. Experience with Class III devices or combination products would be advantageous, but is not essential.
Key Responsibilities
• Support the development and approval activities for a new medical device programme under MDR 2017/745.
• Work closely with global Regulatory Affairs, Clinical Affairs and R&D teams across the product development lifecycle.
• Contribute to regulatory strategy activities and support the definition of EU approval pathways.
• Develop and maintain regulatory plans aligned to product development and submission milestones.
• Provide regulatory input into technical documentation, risk management and clinical activities.
Experience and Skills Required
• Proven Regulatory Affairs experience within the Medical Device sector.
• Strong working knowledge of MDR 2017/745 and associated regulatory frameworks.
• Experience supporting regulatory activities for medical device development programmes.
• Experience contributing to regulatory submissions and technical documentation activities.
• Experience with Class III medical devices, combination products or drug-device products would be advantageous but is not essential.
• Degree qualified within a scientific, engineering or related discipline.
This is an opportunity to join a globally recognised medical device organisation working on a high-profile development programme where Regulatory Affairs sits at the centre of product development and market approval activities. If you enjoy technically focused Regulatory Affairs work, collaborative project environments and supporting innovative products through to market launch, please get in touch with Kris Holmes today or click apply now.