Quality/Regulatory Scientist, Medical Devices
Hours: Monday - Friday 8:30am - 16:30am
Additional: Competitive salary DOE, Parking onsite, private medical, life assurance, company pension, attendance bonus
Our Client, an established Medical Devices company / IVD are looking to recruit for an experienced QA/ RA Scientist to work at their modern R&D facility based on the outskirts of Liverpool.
- The Quality and Regulatory Scientist will work closely with Quality Assurance Manager and assist in ensuring that all aspects of Clients Group QMS remain effective.
- Assist in maintaining compliance with all applicable Quality standards regulatory and statutory requirements necessary to the continued business activities of the Client.
- Assist in ensuring that all documents and information relating to customer regulatory requirements are generated and available as required.
- Investigate and rapidly resolve all complaints relating to Clients products and services, ensuring that the necessary CAPA measures are identified, documented, logged and actioned in a timely manner, in accordance with the Client Group Quality Management System (QMS) requirements and appropriate regulatory requirements.
- Work with R&D staff in the compilation / storage and accessibility of regulatory required product Technical Files.
- Provide support and advice to Company departments in regulatory matters, as required.
- Assist with promoting the principles of regulatory requirements to all staff in conjunction with the QA&QARA Managers, under the overall direction of Top Management (Client Company Directors).
- Work alongside and under the direction of the QA/QARA Managers in any of the following activities as required; identifying and ensuring compliance with all applicable standards, regulations and directives, relating to IVD medical device products, QMS, and other statutory legislation e.g. health and safety at work and environmental management; Ensuring that Client's products are designed, manufactured, marketed, sold and shipped in compliance with current IVD medical device regulatory requirements and other applicable regulations and standards.
- Ensure that Clients products are registered in accordance with all relevant national requirements for each country.
- Ensure that all relevant standards, regulations and directives are identified, kept up to date and copies are available for reference and use by all staff as required.
- ensure that all staff are aware of and trained in standards applicable to their particular areas of the business.
- Develop a good understanding of the Clients Group Quality Management system to assist the QA Manager with maintenance of the same, as required.
- Undertake, coordinate and complete investigations for all company complaints relating to products and services from across the business, e.g. manufacturing, quality control, supplier, service and any other customer related issues. This includes, but is not limited to;
- Ability to be able to understand and prioritise customer complaints
- Work with relevant other departments to fully investigate and determine the root cause of the specific complaint issues raised by the customer, e.g. manufacturing, quality control etc.
- Ensure clear and concise resolution of the complaint in a timely manner.
- Mange and file all documentation relating to customer complaints.
- Assist the QARA team in managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.
- Work with QA/QARA Managers, as required, on any QARA related activities, such as Internal Audits, Document Control, Non-Conformance, Supplier Approval etc.
- Identify, as required, all relevant statutory regulatory requirements relating to design, manufacture and sale of Client's in vitro Medical Device products in any country worldwide and advise the International Sales team of these requirements and any resources required to meet these requirements.
- Assist QARA Manager final sign off of Quality Control documentation as a 'Person responsible for regulatory compliance' in accordance with EU IVD Medical Device Regulation 2017/746.
- Ensure that all documentation relating to compliance to animal biproduct regulations are received for applicable raw materials.
- Ensure that all required aspects of Client's Quality Management Systems are implemented, controlled and managed in accordance with applicable International Quality Management standards.
- Work with Research and Development, and Quality Control staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
- Working as part of the QARA Team to provide support and advice to Company departments in regulatory and quality assurance matters, as required. This includes equipment calibration and monitoring: process verification and validation; document training; Investigation and rapid resolution of complaints relating to Clients Group products; recall and vigilance reporting and liaison with National Competent Authorities as required; ensuring that necessary improvements and corrective and preventative (CAPA) measures are identified and implemented; Internal audit scheduling.
- Assist with aspects of global regulatory enquiries and issues as required.
- Prepare and present any written report and document as directed.
- In addition to the specified duties an employee is expected to perform additional tasks when reasonably called upon to do so.
- Prepare documentation in compliance with the relevant standards and procedures.
- Ensure that all records are accurately documented and securely retained in a filing system (whether by electronic or paper documented means) allowing prompt retrieval.
- Must hold a Degree in a Life Science (Biomedical, Micro, etc) subject.
- A solid understanding of ISO 134845, 9001, 17025 standards and working to these QMS.
- Will have worked in the IVD/ Diagnostics sector.
- The ideal Candidate will have previous regulatory experience.
- Experience in raising non conformances, CAPAs etc is desirable.
- Strong report writing skills, and communicative skills required.
- Will be IT proficient working across a range of software's and applications,