Senior Manager, Regulatory Affairs & Quality

Job Description:

• Ensure compliance of Cardinal Health’s activities in ANZ to the ISO standard 13485 current global & local quality procedures.
• Work closely with all functional departments to meet short term customer quality requirements while implementing business strategies in support of long-term demands.
• Communicate regulatory, quality and compliance perspective effectively to senior management.
• 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.
• 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) in alignment with Cardinal Health’s Medical Device Division QS policies.
• Provide, in coordination with Cardinal Health’s global teams, 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 by monitoring and communicating new and updated regulations and participate in industry association meetings.
• Oversee the complaint handling process, vigilance reporting and local execution of the Field Safety Corrective Notices (FSCNs) initiated by the global team.
• 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.
• 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.
• Mentor supervisors and senior specialists, provide input to and involve in their objectives and performance reviews and ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Own and lead special projects, often complex in nature.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets.
• Performs other duties assigned as needed.

Education/Training/Experience:

• Bachelor's Degree in Science or related field of study;
• 9-12 years experience in the medical industry with at least five (7) years in Regulatory Affairs of Medical Devices.
• Experience leading ISO 13485 and MDSAP audits.
• International regulatory experience an asset.
• Proven expertise in all aspects of Regulatory Affairs and Quality including submission preparation, local regulatory authority device law/regulations, and post market surveillance activities.
• Good project management skills.

• Consistent background and knowledge of MD regulations, ISO 13485 and MDSAP requirements. Relations established with the key interlocutors in the industry (e.g., regulatory agencies such as TGA, professional organizations, etc.).
• Ability to identify early the risks incurred by the company, and propose appropriate action plans, in alignment with Cardinal Health’s global teams.
• Ability to work in team and to share experiences.
• Results Orientation: A leader who takes responsibility for objectives and results; holds oneself and the team accountable for taking action to deliver business results.
• Strategic Thinking: Anticipates complex internal/external business issues that may impact organization. Creates and articulates a short term and long-term strategic plan based on anticipated internal/external trends.
• Customer Focus: Collaborates with key internal/external customers to develop strategies that anticipate and address their business needs and challenges. Leverages knowledge and understanding of customer to develop cutting edge solutions that improve business results and shares key leanings with others.
• Disciplined Execution: Able to solve complex or unusual business problems while remaining process oriented and adhering to details.
• Team Interaction: Fosters long-term relationships with key decision makers within/outside organization; sponsors team involvement; creates an environment in which diversity is utilized as a competitive advantage. Negotiates with customer and/or organizational leadership through effective listening and communication to accomplish broad business objectives.
• Language Requirements: Fluency in English required.

Additional Job Requirements:

• Travel: 20-25% (predominantly to the US, and Singapore [APAC] offices).
• Occasional weekend/ travel work may be required as necessary.
• Key relationships:
  • External: Therapeutic Goods Administration (TGA) and other Regulatory bodies as required.
  • Internal: Quality, Regulatory and Compliance organizations, Operations & Commercial teams.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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