Project Regulatory Affairs Specialist
Main purpose of the job
To take a leading role in the regulatory compliance aspects of multi-disciplinary device development projects in the field of drug delivery products, in-vitro diagnostics, and surgical products. The position will require you to apply your regulatory compliance skills to the development of world-leading medical products for our clients around the globe.
Type of work undertaken by the division/group
The Medical Technology Division undertakes the development of innovative medical devices and equipment from concept to prototype manufacture, often incorporating considerable technical challenges, in the three focus areas of:
- Medical diagnostics and instrumentation
- Surgical products and medical systems
- Drug delivery devices
We combine highly creative lateral thinking with excellent technical skills and a broad base of industry experience to form a powerful development team. Our work ranges from undertaking complete product developments from concept to market, to providing consulting services for our clients on their technology, strategy or development processes.
The division undertakes both client funded and internally funded projects.
Specific responsibilities
This position involves taking the lead role on regulatory compliance within development projects with exposure to all aspects of development from contract negotiation to final delivery. You will be involved in advising the project manager on the quality management system that needs to be in-place for any given project, and the implication this has for the execution of specific engineering design tasks. Significant project management tasks may also be a key part of the role.
You will use your strong regulatory expertise to develop relationships with current and future clients by understanding their needs and by assisting in writing proposals to define the work programmes. You will provide a regulatory point of contact within the company for clients. You will manage tasks within projects requiring delivery within tight timescales and budgets, managing both internal and external resources.
This is an excellent opportunity for an experienced regulatory specialist with the ambition and ability to achieve excellent results in a highly demanding industry and to find novel and radical solutions to new and existing problems under tough commercial, technical and time constraints.
Your specific responsibilities will include:
- Identification of product classification and approval authority
- Definition of regulatory strategy for product or system developments
- Definition of specific quality management processes, within our existing ISO 9001 system, to achieve regulatory compliance
- Identification of compliance tasks in the overall development plan
- Preparation of project quality, risk management, verification and validation plans
- Identification and preparation of design verification protocols
- Preparation of verification and validation reports
- Identifying process validation requirements
Minimum requirements
To meet the requirements of this role you should have a high level of regulatory experience, preferably gained in a R&D environment. Exposure to the healthcare industry is vital, with experience at a pharmaceutical or medical device company being a strong advantage. This experience may have been gained in a regulatory role mainly concerned with the preparation of approval submissions (and experience in European and FDA submissions is preferred), or you may have performed a project QA role. Therefore your degree may be in life-sciences or engineering. In either case your key ability will be skill and experience to interpret downstream requirements into what this means for the development team right now.
Your specific expertise will include some of the following:
- Regulatory/Quality planning
- Risk analysis techniques (eg FTA and/or FMEA)
- Software V&V planning
- SOP preparation
- V&V Protocol preparation
- Design control
- Change control
- Standards analysis
Experience in clinical trials design and planning is desirable, as is the knowledge of the EMEA and FDA approvals process for combination products.
Future Prospects
Cambridge Consultants is committed to developing its employees’ careers and has a flexible policy for individuals' capabilities and preferences. Within the line management structure there are opportunities for promotion to Group Leader with responsibility for managing one of the company’s business areas, or Senior Consultant with recognition for exceptional technical expertise, and beyond to more senior management positions. Cambridge Consultants is a growing company and promotion is linked to merit
Employment benefits
- Good salaries, based on merit and reviewed annually
- Bonus scheme in addition to basic salary
- Flexible working hours
- Free lunches and refreshments
- Private medical insurance and company sickness scheme
- Pension scheme including free life assurance
- 25 days annual holiday plus bank holidays
- Assistance in relocation if applicable
- Active social committee
- Well equipped and pleasantly situated building on the Cambridge Science Park
- Above all, real responsibility for real business problems, with good career prospects based on merit
- Excellent career development and training opportunities
To apply, send your CV to: UKrecruitment@CambridgeConsultants.com