Call Us: +353 1 2784671 Email: [email protected]

QA/RA Director

  • Location:
  • Salary:
    negotiable
  • Posted:
    3 weeks ago
  • Category:
    Medical Devices
  • Deadline:
    Open

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.

If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email [email protected]

See the role at cpl.ie or click here

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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