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QARA Manager - Medical Devices (ISO13485/MDR)
South West London
On site
Salary upon application
ASAP Start
Permanent
OVERVIEW:
The Quality and Regulatory Affairs Manager will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations. The ideal candidate will join a dynamic team launching innovative technology. This is a great opportunity for someone who is a couple of years into their career and looking for more responsibility and ownership including FDA registration process. Training and education provided as required to enable the candidate to develop their potential and build on their skills in an exciting new business.
KEY ACCOUNTABILITIES:
- QMS management (Quality Manual, policy, Quality objectives, QMS planning, QMS meeting, staff training, Change Plan) Management, maintenance, and compliance (ISO13485/21 CFR 820/MDR) with Standard Operating Procedures (SOPs), internal policies related to Quality Management System and their training to the relevant individuals.
- Responsible for management and planning of the internal audit programme and conducting internal audits. Supporting external NB, FDA audits. Liaise with the designated Approved Body and Notified Body to maintain necessary accreditations.
- Post-Market Surveillance activities -Implementation of PMCF plans
- PMS data collection, analysis, reporting
- Clinical Evaluation Report inputs, review and update
- MDR, FDA planning and implementation and regulatory support for other regions.
- Review of Technical Files, Risk Management and GSPR.
SKILLS/EXPERIENCE REQUIRED:
- University degree in relevant life science, scientific or engineering-based discipline
- MS Office (intermediate level) Internet and email.
- Must be fluent in written and spoken English
- A minimum of 2+ years working in an MDD/MDR /FDA Regulatory/ISO13485 environment
- Good understanding of EU MDD/MDR,FDA, ISO 13485 requirements and ability to communicate and provide training on these technical and regulatory documents
- Internal Auditor
Desirable: Experience of FDA submissions
If you do not hear back from Projectus Consulting within 7 days please assume your application has not progressed on this occasion only.
