Job Description

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\xe2\x80\x99re helping to develop solutions that enable accurate diagnoses to turn anxiety into answers. When you join our global team of talented people, you\xe2\x80\x99re 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\xe2\x80\x99s 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 (

5%)

Language:

• Excellent proficiency in English language, both oral and written, is required

Scope of the Role

Supervisory Responsibility: None

Approximate Direct Reports: None

Approximate Indirect Reports: None

Financial Responsibility: None

Domestic/International/Global: None

Peers:

• The RA Officer will work with other RA Officers and RA Associates within the LBS Newcastle Regulatory Affairs Department, as well as liaising with the Global Registrations Regulatory Affairs Teams

Internal Relationships:

• The RA Officer will develop good working relationships with Technical Services, Research and Development, Clinical Affairs, Quality Assurance and Regulatory Compliance teams within LBS Newcastle

External Relationships:

• The RA Officer will interface with external parties such as Notified Body and European Authorised Representative as required

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

When you join us, you\xe2\x80\x99ll also be joining Danaher\xe2\x80\x99s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\xe2\x80\x99ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you\xe2\x80\x99ve ever wondered what\xe2\x80\x99s within you, there\xe2\x80\x99s no better time to find out.

Danaher