Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

• →Prepare and coordinate regulatory submission packages for product registrations, licensing activities, audits, and inspections.
• →Compile and maintain documentation required for submissions, license renewals, and annual registrations.
• →Assess regulatory requirements and recommend actions to support compliance for product labeling, manufacturing, marketing, and clinical activities.
• →Monitor regulatory changes and communicate potential business impacts to relevant stakeholders.
• →Maintain and improve regulatory tracking and document control systems. 
• →Support interactions with regulatory authorities and respond to regulatory requests as required.
• →Contribute to regulatory strategies that support timely product approvals and market access.
• →Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

• Bachelor's degree and 2+ years of experience in Regulatory Affairs within the healthcare industry.
• Experience preparing and managing regulatory submissions, registrations, or license renewals.
• Working knowledge of Quality Assurance and Regulatory Affairs (QARA) operations.
• Proficiency in Microsoft Office applications.
• Experience partnering with internal and external stakeholders to achieve compliance objectives.

• Bachelor's degree in Medical Science, Biological Science, or a related life sciences discipline. [
• Experience with medical device product registrations and licensing activities.
• Experience working within Good Manufacturing Practice (GMP) regulated environments.
• Knowledge of Australian medical device regulatory requirements and regulatory authority interactions.
• Experience supporting regulatory activities across multiple product portfolios.
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Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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