Helena Biosciences is a leading and well established medical diagnostic company, with an international reputation comprising two.....
Helena Biosciences is a leading and well established medical diagnostic company, with an international reputation comprising two flagship business divisions that specialise in the design, manufacture and support of Clinical Electrophoresis and Haemostasis systems.
This vacancy is in the Quality Assurance & Regulatory Affairs Department and is the opportunity to be part of a fast-paced, long-term project as Helena Biosciences Europe transition all of our products into full IVDR compliance and bring new products to the market in the areas of Electrophoresis and Haemostasis.
The candidate would be a highly motivated and self-reliant person with a science background.
QA/RA Officer & Technical Writer
Role Summary:
• To assist the company in meeting its regulatory requirements under Regulation (EU) 2017/746 (IVDR) to be able to market IVD medical devices in the European Union.
• To assist in completion of IVD Medical Device Registrations, continuously support the Registration Processes, Quality Assurance & Regulatory Affairs Processes and to assist in ensuring that devices are in compliance with their Technical Documentation.
Main Duties and Responsibilities:
• To play your part in ensuring that the requirements of Regulation (EU) 2017/746 (IVDR) are met by the company.
• To conduct Technical Writing as co-ordinated by the Technical Compliance Manager.
• To be proactive in your approach to completing documentation required for Technical Compliance with respect to the IVDR.
• Co-Ordination and preparation of Technical Documentation and Declarations of Conformity for the EU.
• To ensure that required continuous professional development is conducted as directed, and as self-directed.
• To maintain high levels of integrity, professionalism & regulatory compliance.
• To be responsive to ad-hoc requests from QA/RA Management and from the Technical Compliance Manager.
• To be proactive and conscientious in your time management, prioritisation of work & commitment to high-priority/time-critical tasks
• To proactively ensure that you are able to competently conduct your job roles to the best of your ability, with the support of other teams within the business.
Key Skills Required:
• Knowledge and Awareness of Quality Management Systems, e.g. ISO 13485, ISO 14971 and the US Quality System Regulation.
• Knowledge and Awareness in Standards & Regulatory Requirements according to ISO 13485:2016, IVDD (98/79/EC), IVDR 2017/746 and other applicable standards and regulations as directed by the Associate Director of QA/RA.
• Knowledge of Good Manufacturing Practices (GMP).
• Knowledge of non-conformity investigation skills.
• Clear attention to detail with regards to existing and new documentation.
• Competent in the use of Internet, Microsoft, Windows programs including Word, Excel, PowerPoint, and other software solutions pertinent to the role (electronic QMS software, IMS software).
• Able to communicate effectively to all personnel within the company.
• High levels of professionalism.
• Professional integrity and conscientiousness in your work.
Experience Required:
• Some experience and background in Medical Device or Pharmaceutical Quality Management and/or Regulatory Affairs Department and/or Technical Writing
• A Scientific Background
Desirable Knowledge & Experience:
• Experience in Product Risk Analysis (FMEAs)
• Experience in the preparation of Technical Documentation and Declaration of Conformity for the EU, or in equivalently scrutinised industry (e.g., Pharmaceutical)
• Knowledge/Experience in Electrophoresis and/or Haemostasis IVD Medical Devices
A qualification in a relevant scientific field is desirable but not essential.
This vacancy is permanent, full time Monday to Friday (daytime hours) and based at our Gateshead site.
Salary: Competitive Remuneration Package (negotiable depending upon skills and experience)
Applications (including your current CV and covering letter) should be
e-mailed to personnel@helena-biosciences.com
www.helena-biosciences.com
Registered in England: 1796207
