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
Lead and manage the product compliance and registration process for local and international regions.Assume the role of Management Representative for regulatory bodies such as TGA, EU, FDA, Health Canada, Brazil, Japan, South America, Asia, Middle East, etc.Ensure processes needed for the QMS are effectively documented to meet compliance requirements.Ensure awareness of applicable regulatory requirements and QMS requirements throughout SDI.Lead and manage SDI's QMS to ensure compliance with regulations such as ISO13485, MDSAP, GMP, etc.Manage and lead SDI's product registration program in a timely manner as required.Manage and maintain systems to keep SDI up to date with changes and ongoing development of QMS and regulatory requirements.Monitor and review activities of regulatory bodies including TGA, MDR, FDA, Health Canada, Brazil, South America, Asia, Middle East, REACH, WEEE, etc.Prepare a regular Regulatory Affairs report identifying and reviewing progress on product registrations and renewals for all key SDI regions.Liaise with SDI offices overseas and distributors on registration requirements and submissions.Monitor and maintain SDI's trademarks and IP related to SDI products.Key Relationships
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.Job Environment
Location : Bayswater.Working hours : 5 day working week.Local, interstate and international travel as required.Essential Qualification / Experience
Degree or Masters of Bachelor of Sciences or Chemical Engineering.Minimum 5 years' experience in the 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 and 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 and 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!
Desired Skills and Experience : Compliance with various regulations of ISO13485, MDSAP and GMP; strong knowledge with regulatory bodies such as TGA, EU, FDA, Health Canada, Brazil, Japan, South America, Asia, Middle East and etc.
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