Regulatory Compliance Lead
2 days ago
We are seeking an experienced Director of Regulatory Affairs and Compliance to join our team at IQVIA Laboratories in Livingston, Scotland.
This is a leadership-level position responsible for ensuring ongoing regulatory compliance within our Central Laboratories functions. You will work directly with customers, third-party providers, and internal stakeholders to assess compliance and provide guidance on appropriate solutions based on intended use of each item/method.
You will also oversee the creation and management of a central repository/knowledge base of regulatory compliance status and ensure the collation of study-specific regulatory compliance documentation as required. Additionally, you will support customer audits/inspections to provide documentation on procedures surrounding regulatory compliance of analytical methods and consumable products used.
About You- Candidates must have at least 10 years of experience in the clinical trial or medical device domain, ideally both, with a deep understanding of current global regulatory requirements, including IVDR and FDA LTD regulations.
- Experience in customer management and strong relationship management skills.
- Good organizational and project management skills.
- Demonstrated proficiency with Microsoft Office and LIMS systems.
- Must understand medical and clinical research terminology.
- Knowledge of global regulatory requirements for conducting clinical trials in central laboratories, including IVDR.
The ideal candidate should possess excellent communication and interpersonal skills, be able to work effectively in a team environment, and have a strong attention to detail.
Salary Information: The salary for this role is approximately £85,000 - £105,000 per annum, depending on experience. A hybrid and flexible working pattern will be considered, with regular opportunities for career development and growth.
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