Quality Assurance / Regulatory Affairs Officer

Quality Assurance / Regulatory Affairs Officer

Attractive salary, with excellent benefits,

Location: Bishop's Stortford, Essex/Herts Border

We are seeking a Quality Assurance / Regulatory Affairs Officer to support this global medical device company in meeting its quality and regulatory requirements. Provide technical support for medical device manufacturing, engineering, and distribution. Use root cause analysis for problem-solving and trend identification. Conduct quality audits across all organisations.

Performance Measures:

Maintain documented quality systems across the group.
Support internal and external audits for compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other regulations.
Prepare and maintain QMS and regulatory documentation.
Assist QA Admin team with product approvals for UK and international markets.
Evaluate suppliers and conduct approval audits.
Document quality audits to meet ISO, UK, European and worldwide regulatory requirements.
Facilitate quality improvement initiatives.
Analyse data for management reviews and non-conformances.
Conduct CAPA and non-conformance investigations.
Review customer complaints and maintain incident reporting.
Meet LSAS objectives and targets.

Core Competencies:

Experience with BS EN ISO 13485 and global device directives/regulations.
Maintain technical/design history files for compliance.
Medical experience in a production/manufacturing environment.
Internal and external quality auditing experience to ISO 13485.
Passion for quality excellence.
Previous quality assurance experience, including QMS documentation.
Knowledge of CAPA and root cause analysis tools.
Practical problem-solving approach.
Understanding of ISO 14971 quality risk management principles.
Self-motivated and team-oriented.
Ability to manage multiple projects.
IT skills, including ERP systems (e.g., Microsoft Dynamics AX 2012).
Attention to detail and flexibility.
Strong communication skills.
Ability to handle stressful situations and controversial issues.
Willingness to learn and develop new skills.
Knowledge of GMP, GDPR, LSAS, and ethical trade issues.

Key Tasks:

Prepare and submit regulatory documentation for market registration.
Support root cause identification and solution resolution.
Conduct and document quality audits.
Maintain risk assessments and clinical review updates.
Support quality awareness and improvement activities.
Create data summaries for trend analysis.
Assist with supplier investigations and LSAS compliance.
Evaluate supplier approval audits and corrective actions.
Conduct complaint investigations.
Liaise with other departments on quality-related matters.
Provide information for audits.
Report vigilance incidents to the Regulatory Affairs/Quality Assurance Manager.
Support ERP maintenance of quality modules.
Provide quality and regulatory guidance to the Group companies.
Ensure supplier documentation and highlight supply chain risks.
Adhere to the company's Health and Safety Policy and report hazards/accidents.

Benefits includes:

25 days Holiday, plus Bank Holidays, Pension Scheme, Life Assurance and Long-Term Disability Insurance

Location:

Bishop's Stortford, Essex/Herts Border
This position is based at our client's office in Bishop's Stortford, with the option to work remotely 2 days a week.
Conveniently located near the M11/Stansted Airport junction, the site offers easy access and free car parking.

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