Job Title: Associate Post Market Vigilance Specialist
Location: Hybrid, Sydney, New South Wales, Australia
Time Type: Full Time
Posted On: 25 Days Ago
Job Requisition ID: R25306
Job Description
At Medtronic, embark on a career of innovation and purpose. Join a team dedicated to delivering healthcare solutions that extend life, restore health, and alleviate pain. As part of a company built on continuous learning and collaboration, you’ll help ensure patients receive the best products—safely and on time.
A Day in the Life
As an Associate Post Market Vigilance (PMV) Specialist, you will play a key role in ensuring compliance through the oversight of post-market activities. From Field Corrective Actions (FCA) to CAPAs and regulatory reporting, you will collaborate with local and global stakeholders to drive continuous quality improvement while meeting regulatory standards in Australia and New Zealand.
Key Responsibilities
Manage all aspects of Field Corrective Actions (FCA) to ensure regulatory compliance and timely execution.
Review and provide second opinions on regulatory decisions for accuracy and consistency.
Prepare and submit regulatory reports to authorities such as TGA and Medsafe.
Address and respond to regulatory inquiries efficiently and in compliance with timelines.
Develop and oversee Corrective and Preventive Actions (CAPA) to improve systems and address regulatory issues.
Lead or support regulatory projects, ensuring all activities are completed within scope and deadlines.
Collaborate with local field staff to ensure proper handling of complaints and completion of FCA activities.
Maintain communication with internal teams including local/global operating units and PMV groups.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.
0–1 year of experience in regulatory affairs, vigilance, or related field.
Foundational understanding of regulatory guidelines and post-market requirements.
Excellent verbal and written communication skills.
Strong interpersonal and collaboration abilities.
High attention to detail and commitment to data accuracy.
Capable of managing multiple tasks and meeting deadlines.
Physical Job Requirements
This role description outlines the general scope of responsibilities and qualifications required. It does not represent an exhaustive list of all duties associated with the position.
Benefits & Compensation
Competitive salary and flexible benefits package.
Programs and resources designed to support employees at every stage of career and life.
Culture of recognition and career development opportunities.
About Medtronic
Medtronic is a global healthcare technology leader with over 95,000 employees worldwide. Guided by our mission — to alleviate pain, restore health, and extend life — we innovate boldly to address humanity’s toughest health challenges. From R&D labs to production floors, we turn visionary ideas into real-world impact.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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