Regulatory Affairs Administrator

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**Job title**: Regulatory Affairs Administrator
**Reports to**: Senior Regulatory Affairs Specialist

**Location**: Onsite role based at our Manchester HQ located at Manchester Science Park, M15 6SH

**Contract Type**: Full-time, Permanent

**Salary & Benefits**: Competitive Salary + Benefits Package

**About Yourgene Health**:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science. Our mission to enable scientific advances to positively impact human health remains at the core of our focus. It drives and motivates us to develop class leading products and services to meet our customers’ needs.

In addition, we offer a portfolio of screening products in reproductive health, precision medicine and infectious disease including screening assays for cystic fibrosis and DPYD genotyping to prevent chemotoxicity.

Yourgene Genomic Services provides a range of genetic analysis services for our clinical, research and pharma customers to support partners with DNA extractions, biobanking, genotyping, arrays and sequencing workflows (WES and WGS). Yourgene Genomic Services offers a Non-Invasive Prenatal Testing (NIPT) Service, enabling clinics to run their own NIPT service for pregnant women with our prenatal screening tests and service laboratory based in Manchester.

Yourgene Health is part of the Novacyt group of companies and is headquartered in Manchester, UK with facilities in Singapore and Canada.

**Our Culture**:
Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have many social and wellbeing initiatives run by our Nova Social and Charity Huddle that keep our sense of community and togetherness alive. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.

**Description of role**:
Yourgene Health, part of the Novacyt Group, are recruiting for a Regulatory Affairs Administrator at Yourgene Health is responsible for maintaining the Post Market Surveillance activities in compliance with the IVD Regulation (IVDR) and any other relevant global markets. This role will help to support the effective monitoring of the organisation’s _in vitro_ diagnostic devices, allowing Yourgene Health to remain in compliance with the IVD Regulation by routinely reporting on the safety and effectiveness of devices currently on the market.

**Key areas of responsibility**:

- The maintenance of the Post Market Surveillance schedule in accordance with the requirements of the IVD Regulation (2017/746/EC), TG(MD)R 2002, CMDR SOR-98-282 and The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368).
- The completion of Post Market Surveillance activities on an annual basis and in accordance with the schedule, including:

- Conducting vigilance searches using keyword search terms or product codes of national/international incidents databases such as MHRA Medical Device Alerts and Field Safety Notices (UK), Database for Recalls, Product Alerts and Product Corrections (DRAC) (Australia), Health Canada Recalls and Safety Alerts, Swissmedic (Switzerland), FDA Medical Device Recalls and MAUDE Database (USA), FDA Medical Devices Recalls Database (USA), EUDAMED Vigilance Database and HSA Online Safety, Compliance Application and Registration (OSCAR) System (Singapore).
- Conducting literature searches using scientific databases such as PubMed and the Cochrane Library databases to identify scientific literature pertinent to the device and evaluate its performance in the market.
- Collating the post market surveillance data inputs from all functions into a final report format to either present as a Post Market Surveillance Report, Periodic Safety Update Report or Post Market Performance Follow Up Report.
- Analysing data to form an overall conclusion of the post market activities, whether any further actions are required, whether there are any findings of significance that may affect the risk of the device and/or whether the device continues to perform and is safe and effective in the market.
- Maintain specialist personal knowledge of the regulatory requirements within the operational global markets and disseminate information of relevance within the Regulatory Affairs function.
- Monitor the regulatory environment within the operational global markets, assessing the impact of any new of changing regulations to internal regulatory processes.
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