QA/RA Director

Location
Wicklow (County), Leinster (IE)
Salary
DOE
Posted
28 May 2021
Closes
16 Jun 2021
Ref
CP/JO-2104-466150
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

QA/RA Director

On behalf of my client, I am recruiting for a QA/RA Director.

The successful candidate will be responsible for leading the RA/QA team within the organization, over 2 sites in Europe, to assure compliance to international quality and regulatory requirements for IVD. This role reports to the Executive Director.

Key Responsibilities:

  • Development and implementation of a strong and effective RA/QA strategy.
  • Product submissions/approvals, license renewals, periodic updates, and product company registrations to regulatory agencies (CE, US, China etc)
  • Fulfil role of Management Representative of the Company Management System, and is the main point of contact with QMS certification/notified bodies, regulator, and Competent Authorities (in support of Vigilance reporting as required)
  • Documented QMS.
  • Lead team during external audit (MDSAP) as well as during authorities or customer inspection.
  • Risk Management, Deviation & CAPA Management, Complaint Management, Post Market Surveillance and Quality auditing.
  • Ensure that evolving international standards and regulations of interest are identified and anticipated.
  • Will be the first contact person for all QA/RA matters.
  • Collaborate with other members of management to develop new product and engineering designs and manufacturing and training methods.
  • Achieve financial objectives by preparing the QA/RA budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
  • Contribute to team effort by accomplishing related results as needed.
  • Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.

Qualifications/Experience:

  • Advanced science degree with minimum 10 years’ experience, with IVD industrial experience.
  • Strong RA and QA background for IVD medical devices.
  • Knowledge of global regulatory standards required (EU, China, US) and international registration processes.
  • Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices/ IVD.
  • Comfortable with technical data, and to effectively present and respond to questions on global requirements and practices.
  • Development of the members in the team to effectively execute the RA/QA activities.
  • Knowledge of safety requirements and legal standards.
  • Experience with QA measuring and testing equipment.
  • Comfortable with technical data, and to effectively present and respond to questions on global requirements and practices.
  • Development of the members in the team to effectively execute the RA/QA activities.
  • Knowledge of safety requirements and legal standards.
  • Experience with QA measuring and testing equipment.