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Chief Compliance Officer

2 weeks ago


Melbourne, Victoria, Australia beBeeCompliance Full time $180,000 - $270,000
**Job Title:** Head of Compliance">

This role is responsible for leading and managing departmental activities to achieve strategic goals.

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  • The successful candidate will be responsible for monitoring and maintaining compliance with regulatory affairs requirements.

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  • A strong commitment to the company's values of passion, accountability, respect, teamwork, and innovation is required.

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Key Responsibilities:

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  • Leading and managing the product compliance and registration process for local and international regions.

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  • Assuming the role of Management Representative for regulatory bodies such as TGA, EU, FDA, Health Canada, Brazil, Japan, South America, Asia, Middle East etc.

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  • Ensuring processes needed for the Quality Management System are effectively documented to meet compliance requirements.

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  • Ensuring awareness of applicable regulatory requirements and Quality Management System requirements throughout the organization.

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  • Leading and managing the organization's Quality Management System to ensure compliance with various regulations such as ISO13485, MDSAP, GMP etc.

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  • Key Relationships (internal and external):

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    • All staff on site at SDI particularly QC, R&D, Sales & Marketing, and Production.

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    • SDI offices overseas and key distributors.

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    • Regulatory bodies such as TGA, MDR, FDA, DQS, Health Canada, ANVISA, CSA, Korea, China, etc. Regulatory Affairs and QA consultants.

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    The position requires a degree or Master's of Bachelor of Sciences or Chemical Engineering and minimum 5 years' experience in medical devices industry. Experience in QA and/or Regulatory Affairs management is highly desirable.

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    Personal Qualities:

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    • Strong communication and project management skills.

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    • Excellent interpersonal skills, customer focus, analytical and strategic thinking problem-solving skills.

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    • Depth of knowledge of medical device regulatory requirements at both the local and international level.

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    This role is located at Bayswater and requires working hours of a 5-day working week, local, interstate, and international travel as required.

    ">Required Skills and Qualifications:">
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    • Minimum 5 years' experience in medical devices industry.

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    • Experience in QA and/or Regulatory Affairs management is highly desirable.

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    • Degree or Master's of Bachelor of Sciences or Chemical Engineering.

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    ">Benefits:">
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    • Opportunity to work in a dynamic and innovative environment.

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    • Chance to develop skills and expertise in regulatory affairs and quality management.

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    • Competitive salary and benefits package.

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    ">Others:">
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    • Location: Bayswater.

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    • Working Hours: 5-day working week.

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    • Travel Requirements: Local, interstate, and international travel as required.

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