What you need to know
An exciting opportunity has arisen with one of our key clients in the Medical Device industry. Based in the Midlands, you will join the team as a Regulatory Compliance Engineer and will work closely with the QA, RA and QC Managers on all quality and regulatory matters on-site, including the coordination and maintenance of the QEMS.
This is a permanent job and comes with a good additional benefits package.
Your new job
As well as assisting the various Quality Managers, you will also get to deputise for them as and when required. Therefore, this would be a great role for an experienced Quality professional looking to gain the experience needed to move into a leadership role, without having responsibility of any direct reports.
Key duties & responsibilities:
- Control and implement internal and external audits – planning and tracking
- Manage CAPA processes
- Engineering Change Request processes
- Document Control
- Management Review and Monthly Operations Reports
- Vendor Management Process
- Assist with regulatory requirements related to REACH, RoHS & CLP.
What are we looking for?
- Degree qualified or higher in Quality and/or Technical with focus on Medical or Pharma sectors.
- 5 years’ experience working in a regulated environment (Med Dev/Pharma)
- Essential to have experience of customer and regulatory audits relating to ISO 13485 and/or FDA QSR 21 CFR part 820.
- Knowledge of ISO 14001
- Must have in-depth knowledge of Medical Device ISO and FDA Regulations
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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