Regulatory Affairs Specialist

About This Role

This role focuses on providing company-wide regulatory support to project teams, spanning both medical and non-medical disciplines, and supporting the QA Director and Regulatory Affairs Manager with operational activities of the Quality Management System and related management systems. It is a great opportunity to gain experience in a variety of different market areas and expand knowledge across multiple industries.

Responsibilities

• Use experience in compliance to product regulations and quality standards (ISO 9001:2015, ISO 13485:2016, FDA QMSR 21 CFR 820) to provide a strategic advantage to client projects while expanding knowledge and experience of European, US and Asian regulations (for both medical and non-medical applications)
• Take initiative in identifying and monitoring key changes in relevant international regulations, guidance and standards, and interpret and communicate what they mean for both the QA team and the wider business
• Lead communications on quality and regulatory updates and run internal improvement initiatives, owning meaningful contributions to CC’s global systems as a quality and regulatory technical lead
• Working alongside colleagues in QA and the wider business, support the fulfilment of external audit requirements
• Strongly demonstrate and develop leadership and project management skills to facilitate the work done by client project teams
• Apply excellent attention to detail, quality assurance expertise and a collaborative approach to process improvements and the maintenance of QMS documentation
• Find pragmatic but robust solutions in problem-solving under tough commercial, technical, time and regulatory constraints
• Understand and demonstrate the need to balance freedom to innovate on the one hand, with rigour in the design process on the other by applying knowledge and experience of quality management appropriately to the individual project situation
• Be resourceful in approach to contribute to projects with a widely varying breadth of disciplines, scale, complexity and requirements

Requirements

• Clear thinker, who can work independently, flexibly and inventively to facilitate others and show leadership in managing and undertaking activities
• Proactive communicator and has the ability to develop relationships across a range of stakeholders, takes ownership of initiatives, delivers results, and strives for continual improvement
• Demonstrated track record of developing and executing regulatory strategies that align with business needs and deliverables
• Skill and experience to interpret regulatory and standard requirements to clarify the downstream implications for processes
• Knowledge of medical device compliance requirements

About the Company

Cambridge Consultants is a global technology and product development consultancy that helps ambitious organisations turn complex ideas into commercially successful products and services. They combine strategy, science, engineering and design to solve tough technical challenges across a variety of industries.