Quality & Regulatory Affairs Advisor

**Position Overview**:
As a Quality and Regulatory Affairs Advisor, you will Interface with local Cordis Operations, Quality Management and Development to assure all products and processes are in accordance with company standards and quality systems. This is accomplished through Strategic Quality Planning, Quality System execution and maintenance, non-conformance, corrective and preventive action reporting and follow-up, quality audits, performance metrics and continuous improvement projects.

You will be expected to act as the Company Sponsor per regulatory requirement for the national regulatory authority - Therapeutic Goods Administration (TGA). Execute quality and regulatory processes, including regulatory submissions and regulatory product life cycle management.

Guarantee that quality & regulatory requirements are met regarding local and national laws and Cordis’s Medical Device Division standards are in order to place and/ or maintain products on the markets. Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in country.

**Duties & Responsibilities**:

- Ensure compliance of Cordis Medical Device Division activities to the ISO standard 13485 current Quality Manual revision.
- Work closely with all functional departments to meet short term customer quality requirements while implementing business strategies in support of long-term demands
- Communicate quality operations and compliance perspective effectively to senior management
- Identify the process improvements opportunities and Drive QRA process excellence initiatives in APAC countries by using Lean/Sigma methodology to continuously improve our process efficiency.
- Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the QRA area in which the individual operates
- Develop, deploy, enhance, drive and implement quality improvement projects through in-depth analysis of defect trends, to ensure delighted customers and to build customer and employee confidence in the performance of our products.
- Manage internal and external regulatory audits and inspections.
- Coordinate corrective and preventive actions.
- Manage documentation of the Quality Management System.
- Ensure regulatory compliance for Medical Devices (MDs): access to the market, distribution of the products, life cycle management, and declarations to national competent authorities.
- Review and approve product labeling (e.g., labels, IFU, user manual) and promotional material (external and internal communication) in alignment with Cordis’s Medical Device Division QS policies.
- Provide authorized representatives and manufacturers, regulatory support (communication of regulatory documents or information, answer to regulatory and technical questions on products, agreements) for Marketing and commercial functions, and Customers department (especially for tenders).
- Ensure regulatory and quality training and assessments for marketing and commercial functions, and other concerned employees.
- Contribute to regulatory intelligence (involvement on internal and external working groups, participation at local, national and international meetings and congresses, as necessary).
- Manage the complaint handling process and coordinate Field Safety Corrective Notices (FSCNs) with regulatory Compliance actions.
- Ensure compliance with national regulations and regulating agencies and other international bodies. Interpret the intent of regulations and policies and provide such information to project teams and management.
- Instill and drive a regulatory and quality culture. Establish and support policies and standards for the measurement of new products.
- Develop submissions for Class II, III and IV medical devices for local regulatory authority.
- Conduct submission negotiations with the local regulatory authority as needed, including pre
- submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
- Maintain proficiency on regulatory requirements and develop and maintain rapport with local regulatory body reviewers, project team members.
- Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education of local regulations.
- Assist the marketing/ commercial group in the tendering/bidding process.
- Direct appropriate follow-up actions on any compliance issues
- Excellent knowledge and adherence to all ANZ relevant codes, standards and regulatory requirement
- Drive a culture of continuous improvement through the use of tools to implement change that sustains performance
- Lead the activities of a section, Quality Systems or Quality Operations

**Qualifications & Requirements**

**Education**:

- Bachelor's Degree in Nursing, Engineering, Physical or Biol