Anz Ra Leader

3 days ago

Mascot, Australia GE HEALTHCARE Full time

**Job Description Summary**: This position provides guidance to Australia and New Zealand (ANZ). The individual would be working with a team of Regulatory Affairs professionals to ensure GE HealthCare achieves compliance to applicable regulations. The individual would be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, advertisement review, product compliance, etc. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Essential Responsibilities**: - Provides regulatory input during product development and ensure product compliance - Develops regulatory strategies and help navigate regulatory submission route map - Works with a cross functional team to achieve regulatory excellence - Reviews and assesses changes in existing products to determines for new registration and/or license revision - Plans for renew submission in applicable countries per business needs, to ensure product supply continuity in those countries. - Reviews and approves advertising material to ensure compliance with approved claims and/or other regulatory requirements. - Performs environment scan for new regulatory requirements and organize regulatory intelligence for impact assessment - Supports regulatory inspections/audit as required. - Assess adverse event reportability and perform post market reporting as per country regulations. - Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression - Establish effective and clear communication within RA and other relevant stakeholder and functions - Ensure proper documentation in compliance with QMS requirement **Qualifications/Requirements**: - Ability to communicate effectively in English (both written and oral) - Good communication skills - 10+ years working experience as regulatory affairs in medical device company is preferred. Regulatory Affairs Certification (RAPS) is preferred - Australia TGA experience is preferred **Desired Characteristics**: - Ability to work independently in fast-paced environment with little supervision - Ability to adapt to constant change and influence positive change effectively - Team-oriented and responsive to customer needs - Attention to detail and results-Oriented - Down to earth, practical, and patient Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. - Flexible working options and flexible hours - Competitive salary - 5 weeks leave (ask about "take 5") - Generous leave & family policies - Long term career opportunities (locally and globally) - Generous discounts for goods & services via our employee benefits program (think travel, entertainment & shopping) *This was recently rated as one of our employees favourite benefits LI-BA1 LI-ONSITE LI-HYBRID **Additional Information**: **Relocation Assistance Provided**:No

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