Quality & Regulatory Lead

An international health care organisation is advertising a vacancy for a Quality and Regulatory Lead, based in their London office. This establishment is known for helping people with chronic, complex, and rare diseases whilst working with world-leading healthcare provides and pharmaceutical companies. This is an exciting opportunity to work with a growing team and help shape regulatory and quality management systems.

Job Responsibilities:

• Administering and maintaining controlled documents and records, including the Document Control Master list, in accordance with documented procedures and guidelines.
• Developing and implementing the eQMS, managing the system and supporting teams in its use.
• Developing and delivering training on QMS processes as well as the eQMS.
• Liaising with teams on the approval of new/updated QMS documentation and training requirements.
• Reviewing regulations and international standards and translating requirements to the appropriate sections of the QMS.
• Contributing to Corrective Actions and Preventive Actions processing.
• Managing the internal audits programme and providing support for external audits.
• Deputising for the RA/QA Lead where required.
• Supporting/mentoring the QA Associate and providing development opportunities.
• Supporting the Senior RA Associate in projects where required.

Skills and Requirements:

• Degree in a related field in Engineering, Healthcare, or Law.
• At least 3 years of experience in a Healthcare company.
• Experience with Regulatory, Quality, and Compliance tasks.
• ISO 13485 internal/lead auditor.
• Software development (SaMD) experience or understanding is highly desirable. Interest is a
• must.
• Experience of start-up culture and ways of working is beneficial.
• Experience of ISO 27001 standard in a health/medical software company.
• Experience of regulatory requirements across territories.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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