Quality Assurance Manager and Project CoordinatorCambs-Herts borderPermanentUp to £48k per annumWorking for a specialist provider of biological and clinical samples to the life-science market, to...
Regulatory and Quality Affairs Manager
Up to £60k per annum
This role has come about due to expansion and progression of the pipeline in a fast-moving medical device organisation within the clinical space.
This niche organisation is responsible for delivering projects based on clinical need around patient-safety. They are well-funded and are at a new phase in their growth as they take on new projects which increases their need for a skilled and proficient QA/RA Manager for their site in Cambridge. Reporting to the Technology Development Manager, the key expectations and role requirements are:
- Managing the QMS in accordance with international standards, the requirements of the customer and with best practice relating to ISO 13485, 14001, FDA QSR certifications. Training new staff on Quality expectations and promote a high-level of respect for quality and compliance throughout the organisation.
- Lead on all quality and regulatory aspects around the product development process of the medical devices from concept to launch.
- Responsible for a culture of continuous improvement of management processes within the organisation.
- Brief engineering and product development team on regulatory requirements throughout design process.
- Plan and deliver internal audits.
- Audit of supplier performance and evaluation of effectiveness.
- Engage with global regulatory authorities with relation to QMS and certification of the devices.
- Compile and update product specifications and documentation for initial and ongoing certification.
- Develop and contribute to ongoing Quality KPI's - report as such to the SLT.
- Strategic planning and implementation of RA and QA elements of the progression plan.
- Promote a culture of audit-readiness throughout the extended team, facilitate preparation for audits and act as the go-to person for external regulatory bodies.
- 5 years + background in the medical device space.
- It is essential that you demonstrate previous management of a QMS under ISO 13485, and the MDD/MDR for product development and manufacturing in the UK/EU.
- Good working knowledge of US FDA 21 CFR 820 Quality Systems Regulation, and product approval process.
- Good working knowledge of medical device EU CE marking process and MDD/MDR.
- Excellent awareness of Class I and Class II devices is essential.
- It's highly desirable that you will have worked with process validation and sterile single-use devices.
- You will have knowledge of working with external contract design and manufacturing organisations.
- Excellent project management techniques.
- Self-starter, strong influencing skills and ability to engage both internal and external stakeholders in understanding the gravity of quality compliance and adherence to regulatory guidelines.
- An independent worker, capable of leading and coaching by example.
Does this description interest you, and would it give you the opportunity to use your well-developed QA/RA skills in the exciting field of clinical medical devices?
Apply now by attaching your CV in Word, or contact Bec Johnston for further information on this rare opportunity: firstname.lastname@example.org / 01223 607858.