Quality and Regulatory Assistant

MediTECH (B.N.O.S. Meditech Ltd.); Halstead; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a Quality and Regulatory Assistant to support its Quality Manager. This pivotal role involves ensuring compliance with industry regulations and maintaining the quality management system. Ideal candidates will have experience with ISO 13485:2016 and EU Medical Device Regulations, as well as strong organizational and communication skills. Join a dynamic team dedicated to excellence in medical equipment manufacturing, where your contributions will directly impact product quality and regulatory compliance. If you are passionate about quality assurance and eager to make a difference in healthcare, this opportunity is perfect for you.

Qualifications

• Experience with ISO 13485:2016, EU MDR 2017/745, and UK MDR 2002 is preferred.
• Familiarity with regulatory inspections and audits is beneficial.

Responsibilities

• Support Quality Manager in maintaining ISO 13485:2016 QMS.
• Conduct internal audits and manage medical device lifecycle.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Organisational Skills

Communication Skills

Microsoft Office Suite

ISO 13485:2016 Internal Auditor

Education

Bachelor’s degree in Quality Assurance or Life Sciences

4 years’ experience in QA/RA role

Job description

Meditech is an Internationally recognised British Medical Equipment Manufacturer specialising in Medical Gas equipment for Hospitals and the Emergency services, based in Halstead, Essex, UK.

The company has seen an unprecedented level of demand for its Medical Oxygen products throughout the COVID-19 period, particularly by the NHS. There has been an enormous amount of investment in machinery and manufacturing equipment recently and the company has many new skilled staff working in specialist areas. Another critically important team member is urgently required.

The Job:

The Quality and Regulatory Assistant's role is responsible for supporting the Quality Manager with the organisations quality assurance processes and ensuring compliance with industry regulations. This role requires a strategic approach to ensuring that the company’s products, services, and operations meet both customer expectations and legal requirements.

The ideal candidate will preferably be experienced in ISO 13485:2016, EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002. Knowledge of Class IIa and IIb medical device technical documentation requirements is beneficial.

Key Responsibilities:

Quality Assurance & Control:

1. Maintain the company’s Quality Management system (ISO 13485:2016 QMS) to ensure adherence to industry standards.
2. Conduct internal quality audits to evaluate compliance with established quality standards, identify areas for improvement and follow up on corrective actions.
3. Manage the lifecycle of the medical device, from initial design to placing product on the market.

Regulatory Compliance:

1. Prepare technical file submissions, and responses for regulatory inspections to the EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002.
2. Assist with notified body, customer, and attend supplier audits.
3. Monitor regulatory changes and assist to align internal processes and documentation accordingly.

Documentation and Reporting:

1. Assist with creation, maintenance, and review of quality-related documentation (Procedures, protocols, and validation reports).
2. Maintain accurate records of quality checks, audits and CAPA.

Cross-Functional Collaboration:

1. Work closely with departments such as Engineering, Design, Sales team, and Customer service to ensure the Quality and compliance are embedded throughout the organisation.
2. Collaborate with stakeholders to resolve quality issues.

Education:

1. Bachelor’s degree in quality assurance, Life Sciences, or a related field. Or alternatively a minimum 4 years’ experience in a QA/RA role in Medical Device Manufacturing or Pharmaceuticals.

Experience:

1. Familiarity with industry-specific standards and regulations ISO 13485:2016, EU Medical Device Regulations (MDR) 2017/745 and UK MDR 2002.
2. Experience in assisting with notified body audits.

Skills:

1. Excellent organisational and communication skills.
2. Proficiency in Microsoft Office Suite.
3. ISO 13485:2016 Internal or Lead Auditor qualified preferable.
4. The position will be office based and will involve working closely with cross-functional teams.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Medical Equipment Manufacturing