Regulatory Affairs Consultant

Polytec Personnel Ltd
29 Sep 2016
19 Oct 2016
Contract Type
We're looking for a Regulatory Affairs Consultant who wants a career in regulatory affairs and quality assurance. You'll have experience of product, technical and quality management system standards relating to device design and development. You'll be an experienced 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. You'll 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 project teams around the company. The role will involve supporting a diverse spread of design and development activities across Europe, the US and Asia. What You'll Be Doing: 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 FDAs QSR. Maintaining up-to-date knowledge and understanding of key global regulations and appropriate international standards. Expanding 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 Regulations Providing company-wide communications about key changes in the regulatory field An understanding of the impact to business as and when changes arise. You will be expected to plan an 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 What We're Looking For: You'll 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. A key ability will be the skill and experience to interpret regulatory and standard requirements to ensure the downstream implications for processes are clear. You'll 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. What You'll Get In Return: Excellent salary, based on merit and reviewed annually Company profit share scheme in addition to basic salary Pension scheme & Life assurance plan Private medical insurance & Travel insurance Disability insurance plan Free lunch 25 days annual holiday plus public holidays Relocation assistance if you need it Excellent career development and training opportunities Flexible working hours A thriving social scene This job was originally posted as