Anz Ra Leader

3 weeks 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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