Quality and Regulatory Affairs Manager
- Reference: Quality and Regulatory Affairs Manager
- Closing Date: 14/07/2021
- Type: General Application
SUMMARY OF THE ROLE
To lead the QA and RA functions in implementing and maintaining systems to the highest standard, driving Continuous Improvement and maintaining compliance to ISO 13485, ISO 14971, MDD and MDR. across all areas of the business. To be responsible for CE and UKCA marking of Class 1 and Class 1a medical devices. To act as the person responsible for Regulatory Compliance (PRRC) as defined in Article 15 of MDR EU/2017/745 and as Management Representative as defined in ISO13485.
MAIN DUTIES AND RESPONSIBILITIES
Lead the QARA Department to ensure continued compliance with 1S013485, the Medical Device Directive (93/42/EEC) and the Medical Device Regulation EU/2017/745 as they pertain to both UK and EU along with other relevant regulations e.g. ISO 10993. ISO 11137. ISO14971. The job holder will also report on performance and make recommendations for future improvements as well as liaising with Senior Management
- Promote Continuous Improvement within the company and support the development of LEAN and Six Sigma
- Drive improvements across the business to include the supply chain and distribution to maintain and improve product quality and process efficiency.
- Maintain technical documentation required to support CE and UKCA marking and liaise with distributors worldwide to maintain compliance to local regulations.
- Lead and provide direction and objectives for the QARA team ensuring processes within the QMS are maintained and improvements
- Maintain technical documentation including Clinical Evaluation reports, Technical Files, Risk assessments to meet regulatory requirements.
- Ensure internal audits of the Quality Management Systems are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement.
- Ensure the company is informed of any regulatory changes, assess and report the impact on the company.
- Manage notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely
- Provide progress reports on Departmental KPls and represent the Quality Department during Senior Leadership meetings in order to report status and recommend areas for
- Support the implementation of the Company Health & Safety
- Support new product development ensuring quality plans, specifications, training and full validations are complete and ensure a smooth handover to production.
- Ensure the shop floor is fully supported to ensure manufacturing quality issues (NCRs) are dealt with and closed out in a timely manner. Ensure associated documentation is completed and follow up until actions and documentation including database records are closed
- Manage corrective and preventive actions (CAPAs) and lead CAPA teams as
- Ensure validation of new materials or materials changes through full validation, training, and monitoring.
- Support Continuous Improvement initiatives and communicate progress to Cl teams with regards to key KPls including waste and customer complaints.
- Support change control and ensure the document control system is
- Work closely with Purchasing to establish supplier quality performance criteria and monitor supplier performance, including assessing supplier’s product specifications.
- Approval of suppliers through site visitation and
- Ensure good collaboration with suppliers and the follow up and closure of supplier quality
- Ensure complaints are fully closed out, reported to competent authorities as required and post market surveillance data , including proactive PMCF is collated, trended and
- Work with all departments within the company to ensure efficient exchange of information and support is provided when
- Some travel required to suppliers, distributors and customers
- Responsibility to adhere to the Company’s Health and Safety policy at all times
- Operate and promote the development of quality standards and procedures taking ownership of tasks and to seek new improved ways of doing things.
- Manage the team in line with Company Procedures and Policies and guidance from HR i.e. absence management
- Ongoing development of the individual with regular communication on their performance through regular 121’s and completion of the PDR process
- Working with HR review any training requirements that will ensure continuous development
- Inspire and motivate team members to ensure company and team objectives are met
A degree of flexibility is needed and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role. All duties must be carried out in compliance with company Quality System, health and safety policies and regulations set out in the Medical Device Directive.
Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and procedures.
The company is committed to a culture of continuous improvement. All members of staff are expected to take ownership of tasks and seek new and improved ways of doing things.
This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.
Please view the Person Specification.
For more information, please email Bianca Loucaides (HR Assistant) at firstname.lastname@example.org
A COVERING LETTER AND CV WILL BE REQUIRED WITH ALL APPLICATIONS
Closing date: 14th July 2021