Quality Assurance and Regulatory Affairs Specialist

4 weeks ago

Cambridge, United Kingdom Origin Sciences Full time

Origin Sciences is a start-up biotechnology company based in Granta Park, just south of Cambridge. We develop our own innovative medical devices, which we use in clinical trials to collect a biobank of mucus-based biospecimens. This biobank provides clinical material for our research and development streams to assist with diagnostic development.

Our primary disease area is Colorectal Cancer (CRC).  We are creating a minimally invasive and accurate CRC diagnostic, which will allow the NHS to focus resources on patients with more serious pathologies. Our motivations are to reduce NHS waiting times, enable earlier CRC detection and reduce unnecessary investigations performed on healthy patients.

Our CRC diagnostic is analogous to blood-based liquid biopsies. However, we have the advantage of evaluating material that was collected closer to the pathology of interest.

Requirements

  • Contribute to the development, maintenance, and compliance of the Quality Management System (QMS). With understanding of ISO: 13485. This Role is more QA but knowledge of RA beneficial.
  • Support the implementation and maintenance of the Origin Science electronic QMS (Greenlight Guru).
  • Prepare, review, and implement ISO:13485 compliant SOPs for functions across the business.
  • Contribute to the investigation and analysis of non-conforming product and processes, and CAPA activities.
  • Contribute to the companies Quality Management Review process.
  • Act as an internal auditor of Origin Sciences products, process and systems.
  • Contribute to BSI ISO:13485 audit activities.
  • Assess critical suppliers ongoing suitability, developing and maintaining the appropriate supplier quality agreements.
  • Contribute to the development and maintenance of the Origin Sciences customer complaints procedures.
  • Perform or verify performance of direct reports on completion of QMS duties including but not limited to: specification and process development and implementation, material, part and device inspection and non-conforming materials handling in collaboration with operations, feedback / complaint handling in collaboration with customer service, and CAPAs in collaboration with all departments.
  • Contribute to QMS Management Review meetings which includes preparation and distribution of reports regarding the quality system, quantification the organization’s performance relative to quality objectives and overall QMS effectiveness.
  • Function as liaison with external parties on matters relating to the quality management system such as quality audits by outside parties.
  • Support RA Manager with clinical study documentation, risk management and reports.

Benefits

  • 25 days holiday
  • Pension contribution
  • Hybrid Working

  • Quality Assurance and Regulatory Affairs Assistant

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company's Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and...

  • Quality and Regulatory Affairs Specialist

    2 weeks ago

    Cambridge, United Kingdom Biochrom Full time

    Biochrom is part of Harvard Bioscience (HBIO), a global business providing life science, laboratory apparatus worldwide. Reporting to Biochrom QRA Manager, the **Quality and Regulatory Affairs Specialist** (QRA Specialist) supports our _in-vitro_ diagnostic product registrations, timely undertaking of post market surveillance as well as monitoring...

  • Regulatory Affairs and Quality Assurance Assistant

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company's Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and...

  • Regulatory Affairs Specialist

    2 months ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Regulatory Affairs Specialist £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...

  • Senior QA

    2 months ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Senior Quality Assurance & Regulatory Affairs Specialist Cambridge £45k-£55k (dep on exp) plus bonus and excellent benefits We are looking for a Senior QA & Regulatory Affairs Specialist with excellent academics and experience within a variety of different industries - a mixture of Medical and non-medical. You will be joining a high calibre,...

  • Regulatory Affairs Specialist Us Market

    2 months ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Regulatory Affairs Specialist - US Market £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...

  • Regulatory Affairs Specialist

    4 weeks ago

    Cambridge, United Kingdom Biocrucible Full time

    Sapphiros UK, a pioneering force in medical technology, is on the brink of a new era as we launch groundbreaking products into the market. As we embark on this exciting journey, we are actively seeking an experienced Regulatory Affairs Specialist to join our small but growing team. This is a unique opportunity to be at the forefront of cutting-edge...

  • Commercial and Regulatory Affairs Specialist

    4 weeks ago

    Cambridge, United Kingdom Orion MedTech Ltd Full time

    The Commercial and Regulatory Affairs Lead will serve as a key figure in navigating the landscape of regulatory compliance for medical technologies, thereby enabling successful research, development, and commercialisation of innovative healthcare solutions from inception to implementation for academic, clinical and SME stakeholders. This role requires an...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Quality Assurance Specialist - Cambridge A growing Medical Devices company based in Cambridge is currently looking for a new Quality Assurance Specialist to assist in the development of the QMS system for ISO 13485 standards. They are open to candidates from alternative sectors, allowing for ISO 13485 standards training. You will also be creating and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Cambridge, United Kingdom ProductLife Group Full time

    About the job In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in the United Kingdom. You will integrate a team of dedicated Regulatory Affairs professionals and will have the mission to develop PLG’s local UK Regulatory Affairs presence, taking responsibility for new regulatory...

  • Senior Director, Regulatory CMC Policy

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Turner Regulatory Full time

    Senior Director, Regulatory CMC Policy & Intelligence Superb senior role in Regulatory CMC Policy & Intelligence and a key hire for a dynamic and fast-growing Biopharma. Leadership, influencing and advising skills both internally and externally. This outstanding role requires the candidate to provide EU Regulatory Intelligence expertise in order to steer the...

  • CMC Regulatory Affairs Contract Biologics 12 MONTH

    2 weeks ago

    Cambridge, United Kingdom Hays Specialist Recruitment Limited Full time

    Your New Company:Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment.Your New RoleI am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my...

  • Regulatory Affairs Manager

    3 weeks ago

    Cambridge, United Kingdom Hays Full time

    Your New Company:Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment.Your New RoleI am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my...

  • Associate Director

    4 days ago

    Cambridge, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re...

  • Regulatory Affairs Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract...

  • Regulatory Affairs Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for...

  • Associate Director

    1 month ago

    Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description Regulatory Affairs Associate Director Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. Together we deliver life-saving therapies to patients in need. With...

  • Regulatory Affairs Labelling Manager contract

    6 days ago

    Cambridge, United Kingdom Hays Full time

    Regulatory Affairs Labelling Manager Your new company This consultancy is looking to strengthen their Regulatory Labelling group by taking on an experienced Regulatory Affairs Labelling professional for a contract job. This job is outside IR35 and has scope for extension.Your new role As the Regulatory Affairs Labelling Manager, you would be responsible for...

  • Regulatory Affairs Labelling Manager contract

    7 days ago

    Cambridge, United Kingdom Hays Remote Work Freelance Full time

    Regulatory Affairs Labelling Manager Your new company This consultancy is looking to strengthen their Regulatory Labelling group by taking on an experienced Regulatory Affairs Labelling professional for a contract job. This job is outside IR35 and has scope for extension.Your new role As the Regulatory Affairs Labelling Manager, you would be responsible for...

  • Regulatory Affairs Labelling Manager contract

    7 days ago

    Cambridge, United Kingdom Hays Full time

    Regulatory Affairs Labelling Manager Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.Your new company This consultancy is looking to strengthen their Regulatory Labelling group by taking on an experienced Regulatory Affairs Labelling professional for a contract job. This job is outside...