Regulatory and Information Governance Lead
An international health care organisation is advertising a vacancy for a Regulatory and Information Governance 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 providers and pharmaceutical companies. This is an exciting opportunity to work with a growing team and help shape regulatory and quality management systems.
- Work with the Head of QA/RA and business streams to identify regulatory requirements for projects and territories.
- Collaborate with product and engineering teams to ensure all products meet the applicable regulatory requirements and develop and maintain technical files for Medical Device.
- Advise company of Regulatory changes affecting the Business, Quality Management and medical devices. Implement these changes where necessary i.e. MDR.
- Coordinating with the Clinical Risk Management Lead, control and keep up to date the Risk Management Files and Clinical Evaluation reports for each Technical file.
- Manage post market surveillance activities, complaints, field safety corrective actions, product recalls and medical device reporting of adverse incidents and evaluate to determine any regulatory actions required.
- Ensure the appropriate regulatory requirements are fulfilled for all products.
- Write and edit technical documents.
- Support the implementation and management of the eQMS systems.
- Support the QA/RA Lead with the management of the QMS
- Support/mentor the QA Associate and providing development opportunities.
Skills and Requirements:
- Degree in a related field in Engineering, Healthcare, or Law.
- Ability to prioritise workload in a start-up environment across different projects.
- Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories.
- At least 4 years' experience in a QA/RA role relating to medical devices and Technical file
- Comprehensive understanding and training with ISO14971 Risk Management.
- Good working knowledge of GDPR and DPA & experience with IG requests such as DPIA.
- Understanding of the requirements for Clinical Evaluation according to MEDDEV 2.7.1 Rev 4 and the changes under the MDR.
- Ability to solve regulatory problems in new and innovative ways.
- Experience of start-up culture and ways of working is beneficial.
- Experience of ISO 27001 standard in a health/medical software company
- Lead auditor qualification (ISO 13485).
- 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.
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 Megan Lockey at +44 203 854 2627 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.