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QA/RA Associate
QA/RA AssociateIvoclar Vivadent • Noble Park, VIC, AUS
QA / RA Associate

QA / RA Associate

Ivoclar Vivadent • Noble Park, VIC, AUS
25 days ago
Job type
  • Quick Apply
Job description

The QA / RA Associate supports the Quality Assurance and Regulatory Affairs functions to ensure compliance with quality standards and regulatory requirements. The role is responsible for supporting the maintenance of our Quality Management System (QMS) and regulatory activities within the Pacific business and to assist with training, workplace health and safety activities as required.

Key Responsibilities

Quality Assurance (QA) :

  • Support the maintenance and ongoing compliance of the Quality Management System in accordance with ISO 13485 : 2016 .
  • Develop, review, update, and control documents.
  • Assign, track, and manage Roles & Responsibilities (R&Us) within the Qumas.
  • Conduct and coordinate employee training on quality procedures and regulatory requirements.
  • Support internal and external audits, including preparation of documentation and follow-up of corrective actions.
  • Assist with NC's, AD's. change control, CAPAs, and document control activities as required.

Regulatory Affairs (RA) :

  • Support the preparation, submission, and maintenance of regulatory registrations and listings.
  • Assist with regulatory documentation and communication with regulatory authorities as directed by the RA Manager.
  • Maintain regulatory files and database
  • Assist with MMD functions
  • Support gap analysis
  • WHS and Cross-Functional Support :

  • Provide support to Workplace Health & Safety (WHS) activities, including documentation and training where required.
  • Support additional QA and RA activities as needed to meet business and compliance objectives.
  • Qualifications and Experience

  • Tertiary qualification in science, engineering, quality, regulatory affairs, or a related discipline (or equivalent experience).
  • Experience in a regulated environment, preferably medical devices or life sciences.
  • Working knowledge of ISO 13485 requirements preferred.
  • Strong documentation, communication, and organizational skills.
  • Key Competencies

  • Attention to detail and strong compliance mindset
  • Ability to manage multiple priorities
  • Effective written and verbal communication
  • Collaborative and proactive approach
  • Join us on our journey to shape the future of dentistry

    Ivoclar Vivadent is one of the world's leading dental companies with 3600 employees. We love innovation and we thrive on it. We are known for our long-standing experience and high quality. We are guided by our strong values and the company culture of a sustainably operated family-owned business with a long-term vision.

    Our mission is making people smile

    In order to achieve this goal we are looking for people with good ideas, courage and exceptional drive : focused minds who share our passion. We offer a multifaceted work environment which is characterized by mutual respect and close collaboration. We translate words into action and continue to evolve. Become part of our team today.

    If you believe you have the necessary skills for this position, we would like to hear from you by sending your resume and covering letter addressing the key selection criteria listed above.

    We look forward to receiving your online application!

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    QARA Associate • Noble Park, VIC, AUS

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