Description
Quality Assurance & Regulatory Affairs Manager -Medical Devices - MidlandsA fantastic opportunity has just arisen for a Quality Assurance and Regulatory Affairs Contract Engineer to come in and join a new Medical Devices department within a market leading Pharmaceutical company. This organisation is looking for a leading professional to come in and lead as well as support a collaborative team environment.
The successful QA & RA candidate's responsibilities will be;
- Regulatory compliance of company systems relating to medical development projects
- Lead and develop personnel and manage the performance of medical device directive and FDA quality systems regulation maintaining awareness and communicating information on all relevant changes in Regulatory compliance to relevant departments within the company.
- Have strong capability to manage, lead and support a collaborative team environment as well as leading a multidisciplinary team.
- Motivate and develop a quality team that support the personal growth and culture of compliance.
- Responsibility for management and further development of our ISO13485/QSR compliant development process and you will be expected to maintain an up to date understanding of applicable regulations and standards relating to our medical business
- Responsible for keeping quality support/requirements and determine their potential effects on activities in the region
QA & RA candidate's requirements will be;
- High level of regulatory experience gained in a medical device product development environment.
- Experience in a project QA role, or a regulatory role concerned with the preparation of FDA or European approval submissions.
- Strong business acumen experience working within a high quality environment.
- Proven analytical skills and an ability to proof read and check documentation within a regulated environment; have knowledge of labelling, change control, operations.
- Experience in conducting solutions to new and existing products, knowledge of general regulatory requirements.
- Depth of understanding of healthcare environment and ability to work independently showing the ability to demonstrate initiative and attention to detail, good problem solving skills is vital and the ability to work to deadlines across multiple simultaneous projects.
If you are interested in hearing about this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact me on .
For further information on this opportunity please click on the attached link https://uk.linkedin.com/in/medicaldevicesqara