Suja John
@sujajohn
Investigation and compliance officer with extensive biomedical engineering experience.
What I'm looking for
I am an experienced Investigation and Compliance Officer currently working with the TGA, where I perform high-level compliance and enforcement activities to ensure adherence to relevant regulations and standards. My role involves leading special investigations into legislative breaches and providing clear, accurate advice to businesses, fostering a collaborative environment with industry stakeholders.
Previously, I served as a Technical Specialist at Invacare Australia, where I conducted product demonstrations and provided training to clients in the healthcare sector. My background also includes roles as a V&V Engineer and Biomedical Service Engineer, where I ensured that medical devices met regulatory and safety requirements. My commitment to excellence is reflected in my recognition as the best trainer for new recruits and my ability to resolve complex customer issues effectively.
Experience
Work history, roles, and key accomplishments
Investigation & Compliance Officer
TGA
Oct 2023 - Present (1 year 7 months)
Perform high-level compliance and enforcement activities to ensure adherence to relevant Acts and Regulations. Lead special investigations into breaches of legislation and provide timely information and assistance to businesses.
Technical Specialist
Invacare Australia
Sep 2019 - Apr 2023 (3 years 7 months)
Conduct product demonstrations and trials in the Disability and Aged Care sectors. Provide education to clients and develop relationships with customers and healthcare professionals.
V&V Engineer
Corin
Jul 2018 - Jul 2019 (1 year)
Verify and validate medical device designs to ensure compliance with user requirements and regulatory standards. Conduct tests and maintain documentation of verification activities.
Biomedical Service Engineer
Chemtronics
Nov 2017 - Mar 2018 (4 months)
Install and configure medical devices at healthcare facilities, ensuring compliance with operational standards. Manage asset accounting and equipment handling.
Support Analyst
Pavilion Health
Jul 2016 - Nov 2017 (1 year 4 months)
Provide exceptional support to customers on products at workshops and conferences, focusing on complaint processing and enhancing operational efficiencies.
Test Analyst / QA
UST Global
Sep 2014 - Jan 2016 (1 year 4 months)
Assist in improving business processes in Salesforce by documenting and analyzing requirements, producing data-driven solutions.
Clinical Validation/Product Support
Spacelabs Healthcare
Jun 2011 - Sep 2014 (3 years 3 months)
Initiated Clinical Field Evaluation and provided technical support for product installations, ensuring compliance with ISO and FDA standards.
Clinical Product Specialist
Larsen & Toubro Ltd
Jan 2010 - Jan 2011 (1 year)
Assist sales in achieving revenue targets and provide training on medical equipment operation and maintenance.
Biomedical Engineer
King Edward Memorial Hospital
Jul 2009 - Apr 2010 (9 months)
Service and maintain medical devices in various hospital departments, ensuring operational efficiency and safety.
Education
Degrees, certifications, and relevant coursework
Indian Institute of Business Management
Master of Business Administration, Quality Control & Operations Management
2012 - 2013
Completed an MBA focusing on Quality Control and Operations Management, gaining insights into management practices and operational efficiencies.
Unknown University
Bachelor of Engineering, Biomedical Instrumentation
2004 - 2008
Earned a Bachelor of Engineering in Biomedical Instrumentation, covering the principles of biomedical engineering and instrumentation technologies.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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