QA/RA Manager Medical Devices
Salary: £45,000 - £50,000
Additional Benefits: 5% pension contribution, 25 days hol with 1 day increase per year up to 30 days plus bank hols, Private health insurance and cash back scheme.
Hours: 9am - 5pm Monday - Friday
Our client is an established innovative manufacturer of medical devices and is looking to bring in an experienced manager. With huge plans for the next 6 years and new products being developed; the successful candidate will have a team built around them and given the autonomy to strive.
- Manages and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
- Accountable for all Quality and regulatory requirements for the business
- Accountability for monitoring and maintenance of existing processes
- Accountable for internal and external audits
- Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
- Accountable for the execution of Notified Body audits and track progress of responses
- Accountable for investigating quality issues and interact with products suppliers regarding these
- Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
- Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
- Authorising product release to stock and completion of relevant records upon receipt
- Accountable for the maintenance and generation of technical files, test reports of product conformity according to MDD and MDR.
- Leads and co-ordinates regulatory activities to support assigned projects.
- Ensures effective co-ordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
- Ensures effective planning and tracking of activities.
- Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
- Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements.
- Clearly defines and communicates regulatory strategy in support of new product registration, in line with commercial objectives.
- Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development, registration, lifecycle management and maintenance.
- Develops proposals for initiatives and implements, as required.
You will already have experience in both ISO 13485 and medical device regulations (MDD and MDR) as well as:
- Proficiency in quality systems (ISO 13485), associated documentation
- Proficient medical device industry and medical device regulations ((MDD and MDR)
- Bachelor's degree in a related field
- Minimum 5 years' experience working in Quality and Regulatory roles within Medical devices.