Head of Compliance

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Company

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

Summary of Role

The Head of Compliance is responsible for:

• Leading effective management of departmental activities to achieve company strategic goals and adhering to company policies.
• Providing the leadership and management necessary to ensure that SDI is QMS, legal and product regulations compliant.
• Monitoring and maintaining local and overseas compliance with regulatory affairs requirements.
• Conducting work in a safe manner and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork and innovation.

Specific Responsibilities:

• Leads and manages the product compliance and registration process for local and international regions
• Assumes the role of Management Representative for regulatory bodies such as TGA, EU, FDA, Health Canada, Brazil, Japan, South America, Asia, Middle East etc.
• Ensures processes needed for the QMS are effectively documented to meet compliance requirements
• Ensures awareness of applicable regulatory requirements and QMS requirements throughout SDI
• Leads and manages SDI's QMS to ensure compliance with various regulations such as ISO13485, MDSAP, GMP etc.
• Manages and leads SDI's product registration program in a timely manner as required
• Manages and maintains systems to ensure SDI is up to date with changes and the ongoing development of QMS's and regulatory requirements
• Monitors and reviews activities of regulatory bodies such as, but not limited to, TGA, MDR, FDA, Health Canada, Brazil, South America, Asia, Middle East, REACH, WEEE, etc.
• Prepares a regular Regulatory Affairs report which identifies and reviews progress on product registrations and renewals for all key SDI regions
• Liaises with SDI offices overseas and distributors on registration requirements and submissions
• Monitors and maintains SDI's trademarks and IP related to SDI products

Key Relationships (internal and external)

• All SDI staff on site at SDI particularly QC, R&D, Sales & Marketing, and Production
• SDI offices overseas and key distributors
• Regulatory bodies such as TGA, MDR, FDA, DQS, Health Canada, ANVISA, CSA, Korea, China, etc. Regulatory Affairs and QA consultants

The position is located at Bayswater

• Working hours: 5 day working week
• Local, interstate and international travel as required.
• Degree or Masters of Bachelor of Sciences or Chemical Engineering
• Minimum 5 years' experience in medical devices industry
• Experience in QA and/or Regulatory Affairs management

Essential Skills, Knowledge and Attributes

Personal Qualities

• Strong communication and project management skills
• Excellent interpersonal skills, able to build strong working relationships Customer focus

Knowledge and Skills

• Analytical and strategic thinking Problem solving skills
• Depth of knowledge of medical device regulatory requirements at both the local and international level Demonstrated experience and depth of knowledge of international standards such as ISO13485, MDR, MDSAP, FDA, TGA, MHRA, GMP and or equivalent
• Ability to work collaboratively with both internal and external people across a range of operational functions
• Resourcefulness in identifying solutions to product registration and regulatory challenges

If you have dental, management and strategic experience, please do not hesitate to click Apply, now

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesChemical Raw Materials Manufacturing

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