Aka Ra Program Manager

5 months ago

Mascot, Australia GE Healthcare Full time

**Job Description Summary**: We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.

This position provides guidance to the growing region - A.K.A. (ASEAN, Korea and ANZ) and primarily support ANZ. The individual would be working with a team of Regulatory Affairs professionals to ensure GEHC 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.

**Roles and 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

**Required Qualifications**:

- Minimum 10 years working experience as regulatory affairs in medical device company is preferred.
- Ability to communicate effectively in English (both written and oral).
- Good communication skills.
- Regulatory Affairs Certification. (RAPS) is preferred
- Australia TGA and/or Korea MFDS 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

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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 + bonus + car allowance or company ca
- 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

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