Permanent

Quality & Regulatory Manager

LocationLancashire, North West, England
Salary
SectorCompliance
Job RefBH-97745
ContactWill Godfrey
Published11 days ago

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Will Godfrey

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Overview

This is a fantastic opportunity for a Quality and Regulatory Manager to join a Global Medical Device company based in Lancashire. Leading a team within QA/RA this will suit someone with a strong background in Medical Devices, people leadership, Regulatory Affairs and Quality Management.

Key Responsibilities & Activities

Responsibility for development, implementation and continued improvement of the quality management system and regulatory documentation.
Ensure a robust supply chain is in place to support product conformity.
Development and maintenance of Technical Documentation for regulatory purposes.
Managing the internal, supplier and 3rd party audit programmes.
Liaison with external bodies, customers and suppliers.
The UK Quality & Regulatory Manager is the appointed Management Representative.
Responsible for working within Health, Safety and Environmental standards and procedures.
Aptitude for team work and results orientation.
Aptitude and ability to promote continuous improvement in a busy manufacturing environment.
Experienced in statistical analysis techniques and application.

Job Qualifications, Skills & Attitudes

Ability to plan and organise work load according to priority, business needs and strict deadlines.
Very good verbal and written communication skills.
Attention to details and excellent visual awareness.
Ability to communicate effectively with different stakeholder groups on site.
Ability to present data and information to senior management.
Experience of multi-disciplined management system incorporating ISO 9001, ISO 13485, ISO 14001, ISO 45001 & ISO 50001.
Experience of managing a multi-functional quality and regulatory team.
Experienced in hosting notified body, and customer audits
Experienced internal and supplier auditor.
Experience of regulatory processes including MDD 93/42/EEC, MDR 2017/745, CGMP as detailed in 21 CFR 820, NIOSH 42 CFR part 84 and PPE Directive 2016/425.
Risk Management according to ISO 14971.
Minimum 5 years’ experience in a Quality and Regulatory role.

For immediate consideration please forward your most up to date CV

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

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You will be rewarded with a great salary and benefits including company bonus, so if this sounds of interest please apply ASAP.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

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We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

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