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Regulatory Affairs Officer

2 weeks ago

Newcastle upon Tyne, United Kingdom CY Partner Full time

**Title**: Regulatory Affairs Officer - Post-Market Sustainment

**Salary**: c. £30,000 - £40,000

**Location**: Multiple Sites

**Contract**: Permanent

Are you an individual with a good attention to detail, and the ability to deliver effective customer service regarding the post market surveillance of medical device regulations? A novel opportunity has arisen within a rapidly expanding Medical Device company based in Newcastle-upon-Tyne is now available The company look to hire an individual aligned with their goal of advancing diagnostics.

As a **Regulatory Affairs Officer - Post-Market Sustainment**, you will hold responsibilities in surveying the market after product release regarding Regulatory duties. Providing knowledge and experience in customer complaint processes and adverse events/customer safety issues. You will be able to effectively interact with customers and colleagues and maintain an excellent working knowledge of all relevant regulations, with the ability to work to your own initiative and as part of a wider team. Reporting to Lead RA Officer.

Main Responsibilities:

- Customer complaint processes: evaluate and investigate thoroughly to determine necessary action, compile data to drive product development, and maintain data in Technical Files.
- Post market surveillance: Generate data of the post-market activity for review and presentation to appropriate departments, maintain reports compliant to necessary IVD regulations. Adverse events and patient safety responsibilities (MDR, Vigilance, clinical trials).
- Use Business System tools on a regular basis to continually improve the complaint process and trend product quality Issues.
- Generation and maintenance of quality documents according to procedure, which provide analysis of RAQA needs.
- Support with FDA inspections and audits from RA bodies.
- Make safety and filing decisions for routine matters. Working with management and medical affairs for non-routine or serious events.
- Mentor colleagues with less experience, including RA Officers.
- Establish and maintain strong relationships with stakeholders and staff.
- Maintain a contemporary working knowledge of relevant regulations and requirements.

About You:

- Degree in a relevant scientific field, with experience of increased responsibility in medical device/IVD RA.
- Training or certification in medical device RA.
- Ability to identify and assess patient and user risk.
- Ability to work to own initiative.
- Effective organizational and time management skills.
- Exceptional communication skills. Ability to explain difficult or sensitive information.
- Advanced writing skills with a competency in appropriate software tools to develop and edit documents, procedures, and reports.