Overview

We’re looking for a Regulatory Affairs Specialist to join us, working across multidisciplinary teams to support and enable breakthrough innovation.

Cambridge Consultants is a global technology and product development consultancy that helps ambitious organisations turn complex ideas into commercially successful products and services.

We combine strategy, science, engineering and design to solve tough technical challenges, across a variety of industries, and this role is key to ensuring this can happen.

当社の提供価値

Breakthrough innovation challenges traditional approaches. At Cambridge Consultants our approach to quality applies technical expertise to provide a platform which encourages and facilitates creativity and innovation to meet global regulatory requirements.

The QA Group is responsible for maintaining the quality management system that supports our business processes, complies with regulatory requirements, and satisfies our clients’ expectations.

What you will be doing

We are looking for a Regulatory Affairs Specialist to join our team.

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

Responsibilities

Your responsibilities will be varied and there is plenty of opportunity for your role to evolve over time. We have listed below the types of things you can expect to be doing:

• Use your 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 our 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 your 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. You must 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 your knowledge and experience of quality management appropriately to the individual project situation. 

• Be resourceful in your approach to contribute to projects with a widely varying breadth of disciplines, scale, complexity and requirements.

What you can bring

To be successful in this role, we are looking for someone who:

• Is a clear thinker, who can work independently, flexibly and inventively to facilitate others and show leadership in managing and undertaking activities
• Is a 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.
• can demonstrate a track record of developing and executing regulatory strategies that align with business needs and deliverables
• has the skill and experience to interpret regulatory and standard requirements to clarify the downstream implications for our processes
• Knowledge of medical device compliance requirements