Start date: 1023
The focus of the role is to provide company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Manager and Head of QA with day-to-day QA activities.
If you understand the need to balance freedom to innovate on the one hand, with rigour in the design process on the other, come and use your resourcefulness to contribute to projects with widely varying breadth of disciplines, scale, complexity and requirements.
Are you looking for a career in regulatory affairs and quality assurance? Do you have experience of product, technical and quality management system standards relating to device design and development?
We’re looking for an experienced regulatory affairs practitioner who is able to interpret regulatory and standard requirements and demonstrate a track record of developing, advising and executing global regulatory strategies that align with business needs and deliverables
Main purpose of the job
The Regulatory Affairs (RA) Consultant will work within the corporate QA framework, taking responsibility for day-to-day QA activities as well as keeping abreast of the regulatory changes impacting on our business and offering regulatory support to our project teams around the company. The role will involve supporting our diverse spread of design and development activities across Europe, the US and Asia.
Type of work undertaken by the QA Group
Cambridge Consultants provides stimulating surroundings where leading edge technologies and innovations challenge traditional approaches, so quality management must be flexible and inventive, but still ensure regulatory compliance.
The QA Group is responsible for maintaining company management systems that support our business processes, and which comply with regulatory requirements and satisfy our clients’ expectations.
The group maintains company registrations to ISO 9001 and ISO 13485 for both the UK and US sites (and is currently transitioning to the new versions of these) and other product and process standards central to areas of our business. The group acts as the quality assurance interface with clients, as required, and becomes directly involved in project work where applicable. We work closely with project teams around the company to ensure alignment with our internal processes and compliance to external regulatory requirements.
This is an excellent opportunity for an experienced regulatory affairs practitioner. With your ambition and ability to achieve results across a range of highly demanding industries, you will be able to find pragmatic but robust solutions to new and existing problems under tough commercial, technical, time and regulatory constraints.
The focus of the role is to provide company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Manager and Head of QA with day-to-day QA activities. Medical areas encompass drug delivery, surgical and diagnostic devices; non-medical disciplines include consumer healthcare, industrial and energy, and connected devices.
As RA Consultant, your specific responsibilities will include:
- Offering quality and regulatory support across a diverse range of projects requiring compliance to product and technical standards in addition to ISO 9001, ISO 13485 and FDA’s QSR.
- Maintaining up-to-date knowledge and understanding of key global regulations and appropriate international standards. This will include:
- Expanding our knowledge and application of European, US and Asian standards and regulations for both medical and non-medical applications
- Raising awareness and advising on compliance routes to address new product and technical regulations, such as the new European Medical Device Regulations
- Providing company-wide communications about key changes in the regulatory field
- An understanding of the impact to Cambridge Consultants’ business as and when changes arise. You will be expected to plan our approach and manage activities to ensure compliance
- Ensuring compliance to technical and product regulations across our business via internal discussions and incorporation of requirements into our existing processes and procedures
- Providing regulatory advice to project-based colleagues, offering clear and pragmatic solutions across a diverse spread of projects
- Undertaking system and project compliance internal audits
- Hosting client and notified body audits, and acting as the QA interface with clients, as required
To meet the requirements of this role you should have significant experience within a regulated industry and be able to demonstrate a track record of developing and executing global regulatory strategies that align with business needs and deliverables. Previous experience with medical devices is strongly preferred.
You are likely to have a degree in engineering or the life sciences. In any case a key ability will be the skill and experience to interpret regulatory and standard requirements to ensure the downstream implications for our processes are clear.
You will need to be a clear thinker, who can work independently and show leadership in managing and undertaking activities. You must be a proactive communicator and have the ability to take ownership of initiatives, deliver results, and strive for continual improvement.
You must have the ability to multitask and manage your workload according to internal and external deadlines and priorities.
Cambridge Consultants is committed to developing its employee’s careers and has a flexible policy for individual capabilities and preferences. Promotion is linked to merit.