9 Permanent ISO 13485 Jobs in the East of England

manufacturing. Maintain accurate documentation and lab records. Introduce innovative technologies and make informed recommendations. Manage project scopes, resources, and budgets effectively. Ensure compliance with ISO 13485 standards. Requirements: Essential: Bachelor's degree or higher in a biological-related discipline, with significant post-qualification experience. Minimum of 3 years … experience in people management. Proven ability to lead, motivate, and mentor a team of scientists. Thorough understanding of product design control and ISO 13485 regulations. Extensive experience in molecular biology techniques such as FISH, PCR, DNA manipulation, and fluorescent labelling. Previous work in a regulated, diagnostic environment. Strong … software tools such as BLAST/BLAT and sequence searching methods. Comprehensive knowledge of genomic principles and databases. Additional management experience preferred. Experience in ISO 9001 and ISO 13485 compliant environments, including participation in audits. If you are ready to make a significant impact in a research more »

will be provided to assist carrying out these responsibilities. Main duties will include ? Generating usability documentation for regulatory submission of the product range with ISO practices. ? Leading , running and moderating use studies ? Working closely with the project and wider teams to create a device that meets the customers needs. … travel may be required Candidate Attributes ? Minimum of 2 years experience and relevant qualifications in usability and human factor engineering ? Practical experience ? Knowledge of ISO 13485 Practices. ? Experience in planning and conducting user studies ? Knowledge of use risk management processes ? Documentation writing skills and ability MS office programs … further information or call (01842) 820409 Skills Required Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical components, Qualifications Required ISO13485, Human factor, Usability, IEC62366 Keywords Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical Components/ more »

be responsible for ensuring that the systems and processes in place for current Good Distribution Practice, MHRA guidelines, Home Office controlled drugs license and ISO-9001: 2015 and ISO 13485 standards are adhered to and that the procedures and appropriate training for the team and wider DD … Distribution Authorisation, GDP Guidelines 2013/C 343/01, Human Medicines Regulations 2021 relevant MHRA Guidelines, legal requirements, and updates Ensure compliance with ISO 9001: 2015 and ISO 13485: 2016 standards. Ensure the QMS is implemented and maintained. The RP must approve, sign and date, all … environment Minimum 2yrs experience in a quality managers/Management position Detailed knowledge and understanding of Medical Device legislation Good knowledge and understanding of ISO13485:2016 and associated standards Good working knowledge of product classification for medical devices, specifically selecting appropriate classification, and conformity assessment route. Formal Training in ISO13485 more »

Minimum of 5 years’ experience in developing software and troubleshooting hardware issues. Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304. Significant experience in formal software verification Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »

NeuroTech AIMDs. Understands the end-to-end process for Class III Medical Devices. Has worked with contract manufacturers or built an internal manufacturing capability. ISO understanding across ISO 13485 requirements. How do I apply? To apply for this outstanding opportunity, please contact Nathan Sasso at Pivotal via more »

CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have more »

team in performing environmental monitoring in line with the requirements of Standard Operating Procedures (SOP's). Follow all requirements of working in an ISO 13485/FDA regulated environment. The Senior Quality Control Scientist will have the following skills and experience: Batchelors degree in Molecular … biology or similar (or equivalent experience). Recent and relevant in Quality Control for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment. Hands on experience of PCR and understanding of underlying principles. Familiarity with operating under formal quality systems and practices, such as … ISO13485 and FDA regulations. Practical experience within the Life Science industry would be a distinct advantage. Interested or know someone who might be? If so, get in contact with Darren Holmes @ Vector Recruitment Ltd on 01234 815474 or more »

. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »

concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and more »