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Regulatory Affairs Specialist posted by Seven Resourcing

Applications close in 3 days
£30,000 - £35,000 / year

Job Description

The Quality & Regulatory Specialist with the Quality & Regulatory Manager ensures the company readiness in compliance with standards and certifications.

Assist in performing Post Market Surveillance.
Member of internal auditor team
interact with all areas of the business in order to process/co-ordinate:
customer complaint investigations,
identify incidents of non-conformance
support the company continual improvement and CAPA programme.
approve and implement validation documentation
product CE marking and US submissions
The job holder is an integral member of the quality team in achieving the quality objectives and initiatives for continuous improvement.

Responsibilities & Duties:

Support the Quality & Regulatory manager in the general maintenance of BQMS, regularly update the quality system performance and reporting data
Create, review and update relevant SOPs and Work Instructions needed to support/improve BQMS, Including ownership of the document and data control process
Facilitator of Corrective Actions and provide performance report on periodic basis.
Provide support with CAPA, complaint and product investigation as needed
Provide training including generating training materials to attain necessary competence of personnel and/or increase their awareness of BQMS requirements
Maintain membership & subscriptions (e.g. BSI)
Lead / support regulatory and customer audits ensuring timely closure to open actions Advice / support on regulatory matters as required
To process customer complaints in accordance with company policy and procedure, assigning investigation/action to appropriate personnel and where necessary perform the investigation of the complaint.
To review the outcome of the investigation for suitability and adequacy regarding resolution of the complaint and determining further investigation/follow-up where deemed appropriate.
Ensure any samples received regarding the complaint are properly handled and stored.
Identification of archive sample storage to allow timely sample retrieval in accordance with company procedure.
Perform PMS activities to MDR requirements
Review and approve CE mark and FDA submissions
Develop and implement validation documents in an ISO controlled environment
Knowledge & Experience:

3+ years’ experience in manufacturing environment or equivalent certification
Knowledge of international/harmonized standards, such as, ISO 9001/ISO 13485
Knowledge of QA principles and system concept
Experience in process control improvement projects
Experience in Validation protocols and reporting
2+ years’ experience of CE Marking process and FDA submissions
Behaviours & Skills:

Outstanding written and oral communication
Excellent organizational skills with large volumes of data, documents / records
Excellent interpersonal and influencing skills
Key Performance Indicators:

Production of quality documents in efficient manner
Resolution of NCR issue in reasonable time as defined/agreed
Effective records and traceability management

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