Job Title: Quality & Regulatory Affairs Manager
Location: London, United Kingdom
Industry: Medical Devices
Salary: Contract or Permanent with Competitive salary and great benefits!
- Responsible for aligning the company’s business needs to regulatory and legislative change.
- Manage and lead QA&RA staff.
- Managing policy strategy and regulatory requirements.
- Make sure regulatory compliance is achieved.
As a Quality & Regulatory Affairs Manager you will be responsible for:
- Review and maintain the company quality management system ensuring quality documentation, processes and procedures and compliance to regulatory requirements.
- Managing international product submissions.
- Determine reportable events / incidents and advice the managing director accordingly.
- Manage CAPA system, ensuring system is fully compliant to regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved.
To apply for the role of Quality & Regulatory Affairs Manager you will have:
- A proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485.
- Medical device QA & RA experience.
- Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments.
- Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports.
- Previous Medical Device experience.
- A valid UK driving licence.
If you are curious about this exciting opportunity as a Quality & Regulatory Affairs Manager APPLY NOW and change your life today.
For more information about the role call me Matthew for a confidential chat on 0203 8000 516 or email me on today.
Due to a high number of applicants, only successful candidates will be contacted. A consultant will reach you within 7 working days.