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Home > Life Sciences > QA & RA Manager – Medical Device

Job Reference: HH/HQ1230

QA & RA Manager – Medical Device

  • Sheffield, South Yorkshire, England
  • Permanent / Full Time
  • Life Sciences Team
  • £55000 - £65000

Job Title: Quality Assurance and Regulatory Affairs Manager

Location: Sheffield

Package: Up to £65k plus car allowance

Role type: Full time, permanent

Purpose

Responsible for Quality Management administration and Regulatory Affairs this role reports to the Managing Director.  This person will make significant contributions to the formulation, development, implementation, and administration of Company policies and business goals. Organises, plans, directs, and controls all Regulatory Affairs and Quality Management functions including product registration, complaint handling and reporting, internal and external auditing of the quality systems and supports R&D and Marketing. Develops policies, procedures, and training to ensure efficient and effective operation of the Company quality system and regulatory requirements. Serves as the Quality System Management Representative and Medical Device Person Responsible for Regulatory Affairs and to act as an effective member of the Management team. 

Role Specification

  • To oversee and continually review our quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.  To ensure that we have a sustainable compliant quality management system that fully supports the current and future commercial needs of the business.
  • Manage the Regulatory, Quality and Clinical teams to ensure that all aspects of compliance are achieved.
  • Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
  • Ensure effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory and regulatory compliance and delivery within budgets whilst providing for a high level of internal and external customer satisfaction.
  • Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
  • Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations. 
  • Keep up to date with changes in regulatory legislation and guidelines together with customer practices and changes to device standards and testing in all countries where we market product.
  • Provide sound advice to management throughout the development of new product and product enhancement submissions, to ensure that the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes.
  • Liaise with the company’s notified body / competent authority, and oversee international submission processes
  • Collaborate with the Regulatory Affairs personnel from our distributors and partners, providing assistance for the maintenance of international product registrations.

Person Specification

  • Degree educated, or equivalent, in a life science or engineering discipline
  • At least five years’ experience in an orthopaedic medical device regulatory environment.
  • An in-depth knowledge, and appreciation, of the regulatory requirements for placing class III medical devices on the European market.  Experience of North America, South America, Asia-Pacific markets would be desirable.
  • Strong leadership and influencing skills, particularly in situations where direct manager authority does not exist.
  • Experience building a high performing team, managing the performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organisation
  • Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales.
  • Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.

If this of interest, please click apply now. For more information, please get in touch with Harvey in the Life Sciences team.

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