Quality & Regulatory Manager

**Quality & Regulatory Manager - Medical Devices**

**Salary Guide: Up to £70,000 pa + Excellent Benefits**

**Location: Harlow, Essex**

A Quality & Regulatory Manager with detailed knowledge of Medical Device Regulations is required by a leading manufacturer that develops chemical technology for the treatment of breathable gases.

The Quality & Regulatory Manager acts as the Management Representative and Person responsible for Regulatory Compliance (PRRC) for the company with respect to the requirements of the EU MDR Regulation (EU) 2017/745.

As part of the leadership team, the Quality & Regulatory Manager is:

- Responsible for the development of optimal Quality and Regulatory performance and efficiency thus facilitating the delivery of the company's goals of achieving excellence in Quality, Delivery and Cost.
- Lead the Quality function and are a focal point in maintaining the compliance and effectiveness of the Business Quality Management System (BQMS) of the company.
- Deliver compliance with the applicable regulatory requirements and standards for the product, process and/or service developed, manufactured and provided by Molecular Products Ltd. They also foster a culture of, and must deliver, continuous improvementwhilst promoting/maintaining compliance throughout the organisation.

**Responsibilities & Duties**:

- Colleague compliance to all company and legislative Health & Safety and environmental requirements within the department.
- Conformity of the devices are appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released.
- Technical documentation and the EU declaration of conformity are drawn up and kept up to-date.
Post-market surveillance obligations are complied with in accordance with the manufacturer obligations.
- Reporting obligations are fulfilled.
- Leadership to QA/QC/Regulatory team to motivate and develop colleagues, ensuring that they are well informed and have ownership of their responsibilities.
- Set SMART objectives for the team and conduct reviews in a timely manner.
- Set monitor and report on department Key Performance Indicators, manage the team and process to achieve objectives & KPI targets.
- Managing and maintaining compliance with the applicable medical device regulations e.g., EU MDR. FDA, CFDA and CE/CA marks.
- Managing and maintaining conformance with ISO 9001 & ISO 13485 certifications.
Act as the main contact person in liaison with the national competent authorities and notified bodies.
- Hosting management review meetings & report to senior management on the effectiveness of the BQMS and any needed improvements.
- Hosting of client/3rd party audits and managing any non-conformances to satisfactory outcome.
Management and submission of technical files for manufactured medical products.
- Evaluation and reporting to competent authority any adverse incident arising from customer complaints.
- Providing quality/regulatory input in the NPD/EPD process.
- Managing the internal audit program & provide support to pool of auditors.
- Leading/assisting the investigation of quality issues, customer complaints or product failure.
Periodic reviews of procedures are completed by process owners to ensure effectiveness of the processes is maintained.
- Reviewing and approval of product labelling and marketing materials to ensure compliance with the applicable regulatory requirements.
- Full regulatory support to export markets as required.
- Promoting awareness of applicable regulatory BQMS requirements throughout the organisation.
Control departmental labour numbers/overtime expenditure to meet budgetary constraints.
Liaise with the Technical Development Team in order to project manage new products into production as they transfer into the Manufacturing remit.
- Line/product validations are completed including process capability analysis to guide appropriate action to improve performance.

**Knowledge & Experience**:

- Management position in a manufacturing-based SME environment within a regulated industry (medical device / drug or other suitable industries).
- As the manufacturer's PRRC, the incumbent must have, either a formal qualification (university degree) in addition to a minimum of one year's professional experience in medical device regulatory affairs or quality management; or significant experience inregulatory affairs or quality management pertaining to medical devices.
- Relevant degree in management/manufacturing/engineering or equivalent (desirable)
- Knowledge of Medical Device Regulations (EU/Global) is essential.
- Knowledge of international/harmonised standards, such as, ISO13485, ISO9001, ISO 14971, ISO14001 HSE 18000.
- Experience in: generating comprehensive and effective reports; process control improvement projects & QMS and supplier audits/development.

Salary Guide: Up to £70,000 pa
Location: Harlow, Essex / Hertfordshire border - Free on-site car parking

Sorry that we cannot contact all of you personally, but thanks in advance for your interest.