Regulatory Affairs Officer

2 weeks ago

Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

Nearly every one of us has been impacted by cancer in some way. At Leica Biosystems, our associates know that every moment matters when it comes to cancer diagnostics. When we come to work, we’re helping to develop solutions that enable accurate diagnoses to turn anxiety into answers. When you join our global team of talented people, you’re helping make a difference in advancing cancer diagnostics.

Leica Biosystems is an equal opportunity employer. We value diversity within our organization, we do not negatively discriminate against race, colour, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

**Position Summary**:
This is a professional position with the Regulatory Affairs team at Leica Biosystems Newcastle Ltd. The RA Officer will support site Regulatory Affairs activities to ensure compliance with all global laws and regulations.

**Major Responsibilities**:

- ** Technical File Maintenance**
- Establish and maintain IVDD and IVDR Technical Files for all _in vitro_ diagnostic devices and author, review and approve technical documents as part of the annual sustainment review cycle
- Support Technical File conformity assessment and annual surveillance reviews by the Notified Body and European Medicines Agency, working with cross functional teams to collate responses to reviewer feedback
- ** Product Registrations**
- Collaborate with Global Regulatory Affairs associates to support product registrations including new product development, market expansions, product changes and renewals worldwide
- Prepare submission package to support country specific registration requirements
- Issue Product Release Notifications following successful license approval to enable devices to be launched to the market
- Establish and maintain device listings, license information and UDI data in accordance with local procedures and global regulations eg FDA GUDID, EUDAMED
- ** Compliance**
- Support site Change Request process by completing Regulatory Assessment of changes to determine whether changes have any registration impact, and establishing the need for technical file updates
- Review of labelling, advertising and promotional material for compliance to approved product claims and applicable regulations
- Provide Regulatory Affairs support for site QMS audits by Notified Body, Danaher and other regulatory bodies as required
- Support Regulatory Intelligence projects such as new standard implementation, revised regulatory requirements

**Skills**:

- Strong organizational skills
- Ability to multitask and manage multiple ongoing projects simultaneously
- Strong communication and presentation skills
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports

**Competencies/Behaviours**:

- Ability to work independently
- High level of integrity

**Education**:

- Master’s degree in Science, Medical or Regulatory Affairs

**Experience**:

- Experienced in writing scientific/technical documentation/reports
- Good understanding of immunohistochemistry preferred but not essential
- Knowledge of _in vitro_ diagnostic regulatory requirements preferred but not essential

**Travel**:

- Travel expectations for this role are Low (

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