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European Quality & Regulatory Specialist - Lancashire- Flexible Home Working - Northern

Excellent Package with flexible home working - Regulatory
Ref: 165 Date Posted: Friday 02 Feb 2018
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European Quality & Regulatory Specialist - Lancashire- Flexible Home Working

Our client is a multi-million pound, globally recognized market leader in providing groundbreaking biomaterial solutions widely used within medical devices and other high technology industries. They have developed revolutionary technology that has been at the forefront of their industry for over 15 years with a consistent focus on innovation and new product development. Through hard work, drive and ambition to deliver outstanding results, they have cemented themselves as one of the most forward-thinking and dynamic places to work in the manufacturing industry.

 

The Opportunity

 

We’re on the lookout for someone with the meticulous mindset of Bill Gates and an eye for detail that would rival Poirot.

 

As the European Quality & Regulatory Specialist, you will be the lead on project teams to ensure quality assurance and regulatory compliance is met for all relevant products and services throughout their full product life cycle. You will define, manage and implement plans to achieve Quality & Regulatory compliance, whilst making sure all customer complaints, Corrective and Preventative Actions (CAPA), Root Cause Analysis (RCA), Master Files, Technical Files and internal/external/supplier/regulatory audits are all achieved in adequate timescales.

 

Defining and managing testing activities for products to demonstrate quality assurance, safety and efficacy is a highly important part of this role, as you will be required to make recommendations on appropriate actions to resolve any issues throughout the product lifestyle. Furthermore, you will be managing Quality Engineers and Technicians whilst liaising with internal and external customers in support of QA/RA activities and queries including impact on product use.

 

Knowledge, Skills & Experience

 

Knowledge 

 

  • Knowledge Quality System requirements 
  • Knowledge of Regulatory compliance activities 
  • Understands validation protocols and requirements 
  • Knowledge of risk management processes and risk assessment methods/tools 
  • Understanding of the design process and composition of regulatory design files 
  • Basic experience of the regulatory process for product registrations 
  • Understanding of the requirements and composition of Technical Files

 

Skills 

  • Technical data analysis and interpretation skills 
  • Excellent communication skills both written and verbal including report writing skills 
  • Excellent organisational skills 

·      Trained ISO internal auditor 

 

Experience 

 

  • Experience operating in a highly regulated industry 
  • Experience of Quality Management Systems for relevant market sectors 
  • Experience of the auditing process in a regulated industry (ISO 13485, MDD and FDA QSR) 

 

The Next Step

 

Medical Engineers would invite enquiries from research and development leaders from the medical technology and other highly regulated industries, regardless of your current team size and structure we will treat all communication in strict confidence. 

 

Calls can be arranged outside office hours, please let us know in your communication and we will get this arranged at a time to suit you.

 

Contact: Jonathan Sleight

Direct 0161 2600 193

Email: jonathan@medicalengineers.co.uk

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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