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QA/RA Manager

Anderson Wright Consulting Ltd
Job LocationSt. Neots
EducationNot Mentioned
Salary£50,000 - £70,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

QA / RA MANAGER – MEDTECH COMPANY – CAMBRIDGESHIRE – FULL TIME - £50,000 - £70,000 BASIC SALARYOur client is seeking for an experienced QA/RA Manager to join their team on a permanent, full time basis at their new premises in Cambridgeshire.This is an opportunity to join an early-stage but rapidly growing MedTech company at a senior level and to share in their success as they grow.You will be responsible for the management and development of the Quality Management System (QMS) and regulatory obligations of the organisation and its products throughout the full product lifecycle.THE ROLE

  • As a QA/RA Manager your role is to manage and review quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities
  • Accountable for all Quality and Regulatory requirements for the business
  • Accountable for monitoring and maintenance of existing processes
  • Accountable for internal and external audits
  • Accountable for the execution of Notified Body audits and track progress of responses
  • Accountable for investigating quality issues and interact with products suppliers regarding these
  • Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
  • Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
  • Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
  • Take the lead role in the assembly of our Technical File for submission to healthcare regulatory agencies internationally
  • Provide guidelines, support and training to staff in the operation of quality assurance and control methods to ensure that the companies policies and up to date and meet the requirements of international regulators
  • Work closely with the technical and production team to improve production processes and quality control, in order to obtain CE mark
  • Authorising product release to stock and completion of relevant records upon receipt
  • Lead and co-ordinate regulatory activities to support assigned projects.
  • Ensure effective co-ordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
  • Ensures effective planning and tracking of activities.
  • Ensure that budgets and forecasts are developed, and actuals managed in line with corporate requirements.
  • Clearly define and communicate regulatory strategy in support of new product registration, in line with commercial objectives
  • Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development, registration, lifecycle management and maintenance
  • Develop proposals for initiatives and implements, as required
    • THE PERSONThe successful QA/RA Manager will already have experience in both ISO 13485 and medical device regulations (MDD and MDR)
  • Minimum 5 years experience working in Quality and Regulatory roles within Medical devices
  • Proficiency in quality systems (ISO 13485), associated documentation
  • Proficient in medical device industry and medical device regulations ((MDD and MDR)
  • Risk management ISO 14971 experience
  • Bachelors degree in a related field
  • Have strong communication, interpretation and presentation abilities
  • Be passionate about technology, healthcare and entrepreneurship
  • Be an excellent written and oral communicator
  • Be driven, motivated and organised
  • Be a team player with demonstrable leadership potential
  • Be a quick learner willing to throw themselves into new challenges
    • THE PACKAGE
  • £50,000 - £70,000 Basic Salary (Subject to experience)
  • 25 Days Holiday + Statutory days
  • Pension Scheme (up to 5% contribution)
  • Varied day to day challenges and tasks
  • Key involvement from inception with a fast growing start up business
    • PLEASE NOTE – ONLY SHORTLISTED APPLICANTS WILL BE CONTACTEDFollow us on twitter @ andersonwrightconsultingltdIn respect to the above role(s), Anderson Wright Consulting Ltd operates as an Employment AgencyQA / RA MANAGER – MEDTECH COMPANY – CAMBRIDGESHIRE – FULL TIME - £50,000 - £70,000 BASIC SALARY

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