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.
We are seeking an experienced and proactive contractor to support our regulatory and quality functions in CE marking a Class I medical device. This full-time, 3-month contract will involve close collaboration with the Head of Regulatory Affairs and the Head of Quality to ensure that the product meets all regulatory requirements.
Responsibilities:
* CE Marking Support: Lead the development, preparation, and writing of CE marking technical documentation for Class I medical devices in compliance with applicable regulations and guidelines.
* Regulatory and Quality Support: Provide hands-on support to the Head of Regulatory Affairs and the Head of Quality in regulatory strategy, technical documentation, and quality management system (QMS) activities.
* Risk Management: Conduct and advise on Design and Product Risk Management activities in alignment with ISO 14971, ensuring appropriate risk assessment and mitigation.
* Post-Market Surveillance: Assist with post-market surveillance (PMS) and vigilance activities to ensure ongoing compliance after the product is released on the market.
* Team Collaboration: Work closely with internal stakeholders, providing regulatory and quality expertise to ensure alignment with both the regulatory strategy and quality system requirements.
Minimum Requirements:
* Experience: Proven experience and track record in regulatory affairs with medical devices, specifically for CE marking Class I medical device procedure packs.
* Hands-on Expertise: Strong hands-on experience with Risk Management according to ISO 14971 and preparing technical documentation for medical devices.
* Regulatory Knowledge: In-depth working knowledge of the European Medical Device Regulation (MDR).
* Post-Market Experience: Practical experience in post-market surveillance and vigilance requirements for medical devices.
* Technical Background: Experience in design control and development of medical devices (R&D or manufacturing).
* Collaboration Skills: Ability to work closely with cross-functional teams, providing regulatory and quality support while maintaining strong communication and organisational skills.
* Degree: A degree in a relevant scientific field such as molecular biology, biomedical engineering, or a related discipline is preferred.
* Fluent in English: Strong verbal and written communication skills in English.
* Independent and Pragmatic: Self-motivated and adaptable, with a problem-solving attitude in a fast-paced environment.
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