Regulatory Affairs Associate

4 days ago

York, United Kingdom Abingdon Health Full time

Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19. We take projects from initial concept through to routine and large-scale manufacturing and have also developed and marketed our own labelled tests.

We offer product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health has also developed AppDx®, a customisable image capturing technology that transforms a smartphone into a self-sufficient, standalone lateral-flow reader.

We are extremely passionate about our people and we now have an exciting opportunity for a talented and enthusiastic individual to join the Project Management Team

**The Role**

This role is within the QARA team and is responsible for providing regulatory support for products that are manufactured and/or marketed by the Company and provide project coordination and support for clients of Abingdon Health's Regulatory Service.

**The role responsibilities**:

- Updating and maintenance of databases and licences held by Abingdon Health.
- Preparation, submission and tracking of documents (such as Dossiers, Product Information Files, Technical Files and artworks) for regulatory submissions. (FDA, CE, UKCA)
- Conducting post market surveillance
- Provide ongoing regulatory advice to project teams throughout product and process development, ensuring regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
- Coordinate projects for clients of the regulatory consultancy service.
- Managing the project plans to ensure delivery, including working with multiple internal stakeholders/departments
- Co-ordinating, running and minuting of project meetings
- Management of project document in line with organizational procedures
- Communicating with customers throughout the project lifecycle
- Assist in external audits (BSI, FDA, MDSAP) and/or regulatory inspections.
- Building relationships with internal and external stakeholders (including Notified Bodies) using best practice
- Assist in correspondence with regulatory agencies, auditing organisations, and notified bodies and respond to quality deficiencies; to produce/update documents related to compliance to the respective standards.

**Essential Knowledge, Skills & Experience**:

- 1-2 years experience in a quality assurance role within an ISO 13485 environment
- Ability to plan and prioritise workload
- Adaptability to be able to thrive in continually evolving environment
- Team player, working with cross functional departments
- Adaptable and willing to expand knowledge across other areas
- Ability to multitask and adhere to internal and external deadlines
- Work in a pressurised, fast-moving environment
- Clear communicator, both written and oral
- Demonstrated ability to maintain attention to detail

**Desirable Knowledge, Skills & Experience**:

- Experience in Regulatory Affairs within a medical device company
- Knowledge of IVDR requirements

**Salary**: Up to £30,000.00 per year

**Benefits**:

- Additional leave
- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Discounted or free food
- Free parking
- On-site parking
- Referral programme
- Sick pay
- Wellness programme

Schedule:

- 8 hour shift

**Experience**:

- Quality assurance or Regulatory: 2 years (required)

Work Location: One location

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