Regulatory Affairs Department Leader

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Regulatory Affairs Department Leader, Edinburgh

Client: SRG

Location: Edinburgh, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 511b6dc1a281

Job Views: 4

Posted: 27.05.2025

Expiry Date: 11.07.2025

Job Description:

SRG is working with an exciting biotechnology organization with a global presence to find a Department Lead within Regulatory Affairs (RA).

This role is ideal for someone with extensive experience in Regulatory Affairs within IVD/IVDRs, offering an excellent benefits package and leadership opportunity.

The role includes:

• Serving as a member of the Regulatory and Quality Management Team to oversee RA and Quality strategy and activities
• Managing, preparing, and maintaining regulatory documentation for compliance with ISO13485, EU directives, FDA regulations, and international requirements
• Interpreting legislation and advising on US FDA, European, and global regulatory laws
• Implementing the company\’s Quality Policy to ensure compliance with cGMP, ISO13485, and relevant regulations
• Designing and improving quality systems and processes for continuous quality improvement
• Leading product license application processes and liaising with regulatory agencies
• Supporting international registration and approval submissions
• Preparing technical files and regulatory dossiers for product licensing
• Reviewing data from laboratory and clinical evaluations to support registration
• Advising on data requirements and coordinating regulatory submissions
• Assessing product changes for impact on existing registrations
• Leading the RA team in regulatory change assessments
• Serving as the company\’s contact for regulatory activities with partners

Requirements:

• A relevant degree or professional qualification with extensive regulatory experience
• Proven experience in US regulatory applications (BLA, 510(k), PMA) and EU CE marking (IVDD/IVDR)
• Post-market experience ensuring ongoing compliance
• Specialist knowledge of in vitro diagnostic medical devices and manufacturing operations
• Understanding of budgeting and departmental management
• Previous management experience with leadership skills
• Strong relationship-building, negotiation, and influencing skills
• Excellent time management and adaptability in a fast-paced environment
• Commitment to ongoing learning and knowledge transfer

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