Description
I hope you are well, one of my larger Medical Device/Diagnostic clients in the North East has had a small restructure is now looking for a Senior Quality & Regulatory affairs manager £75,000-£85,000 +Benefits.My client is a global business that is at the cutting edge of science in the diagnostics industry, this opportunity is a senior post with a focus on the QA side of the business but will also have some responsibility over their pre and post Regulatory Affairs function. However there is a respectable amount of support on site here already. They are looking for someone who can operate with a local mindset at the same time as interacting and moving with a global business.
General Responsibilities Include;
- Leadership and management of QA, QC and post-market RA groups directly or indirectly through subordinate supervisory staff.
- Responsible for ensuring all post-market quality system and regulatory affairs requirements are met by the department.
- Responsible for collaborating and supporting all the premarket regulatory affairs and design assurance team to ensure all initiatives are completed in a timely and compliant manner.
- Responsible for ensuring all quality control requirements are met by the QC group.
- Maintenance of the quality function with compliance to ISO 9001, 13485, FDA, CMDR, and corporate standards.
- Identify and implement/re-design process improvements in the Quality operation.
- Identify issues that arise in Quality in relation to products and be able to investigate and resolve problems as they arise.
- Ensure all Quality staff are trained to be competent in all areas as detailed on the Quality Skills assessment and training needs identified during staff appraisals.
- Writing monthly reports and also as requested
- Identify the need for Capex items for annual budget, also monitor budget for tissue procurement.
- Financial sign-off for departmental purchases
Essential requirements.
- Working knowledge within IVD (preferred) / Medical Devices experience and histology knowledge.
- Experience in direct line management of QA, QC and/or RA teams in a regulated environment.
- Strong management experience coupled with team leadership
- Relevant experience with increasing levels of responsibility managing medical device quality systems.
- Familiar with the activities to be carried out within the appropriate procedures for Quality System to ISO 9001, 13485, FDA and CMDR standards
- Experience of internal and external audits
- Familiar with the regulations of the Human Tissue Act
- High attention to detail.
- Good communication and influencing skills.
- Able to deal with issues confidentially.
If you believe you have the correct experience for the position, my client are currently shortlisting so please send me your CV and I will be in touch shortly.