Chemist jobs in Astwood Bank

We are an established medical device manufacturer and supplier based in Worcestershire and are looking for an experienced Regulatory Affairs & Quality Assurance Manager (QARA) to take ownership of our regulatory and quality activities.

This is a hands-on role with responsibility for maintaining our existing medical device technical documentation, Quality Management System and ongoing regulatory compliance.

A key part of the role will be maintaining and regularly reviewing six existing medical device technical files covering single-use surgical instruments, diathermy instruments and surgical procedure packs.

KEY RESPONSIBILITIES

• Maintain and review six existing medical device technical files covering single-use surgical instruments, diathermy instruments and procedure packs.
• Maintain compliance with applicable UK Medical Devices Regulations and UKCA requirements, including technical documentation, declarations, product registrations and regulatory records.
• Maintain and develop the existing ISO 13485:2016 Quality Management System and support continued certification.
• Maintain the ISO 14001 Environmental Management System and associated procedures and records.
• Manage and support internal and external audits, including preparation for certification and surveillance audits.
• Manage non-conformances, CAPA, document control and management review activities.
• Maintain appropriate medical device risk management, post-market surveillance, complaint handling, vigilance and product traceability processes.
• Support supplier quality management, incoming product controls and investigation of product or supplier quality issues.
• Monitor changes to relevant medical device regulations and standards and advise management on any impact on products, technical files or quality systems.
• Support new product introductions, technical documentation updates and future regulatory submissions where required.

ABOUT YOU

We are looking for someone with previous experience in a Quality Assurance, Regulatory Affairs or combined QARA position within the medical device sector.

You should have:

• Strong working knowledge of ISO 13485:2016.
• Experience maintaining medical device technical files and technical documentation.
• Knowledge of UK medical device regulatory requirements and UKCA conformity processes.
• Experience managing or supporting internal and external quality audits.
• Experience of CAPA, non-conformances, document control and quality management processes.
• An understanding of medical device risk management and post-market surveillance.
• Excellent attention to detail and strong written, organisational and communication skills.
• The ability to work independently and take ownership of the regulatory and quality function.

DESIRABLE EXPERIENCE

Experience in any of the following would be particularly advantageous:

• Single-use or reusable surgical instruments.
• Diathermy or electrosurgical instruments/accessories.
• Surgical procedure packs.
• Sterile medical devices.
• ISO 14971 medical device risk management.
• EU MDR 2017/745.
• MHRA registrations and regulatory interactions.
• Working with UK Approved Bodies.
• Sterilisation, packaging or shelf-life validation.
• Internal or Lead Auditor qualifications.

WHAT WE OFFER

This is a full-time, permanent opportunity offering a competitive salary dependent upon experience.

The successful candidate will have the opportunity to take ownership of an established regulatory and quality function, work closely with senior management and play an important role in maintaining regulatory compliance while supporting the future development of the business and its medical device portfolio.

Pay: £40,000.00-£60,000.00 per year

Benefits:

• On-site parking
• Private medical insurance

Work Location: In person