Senior Quality Assurance and Regulatory Affairs Analyst

• Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

  
  

  At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

  
  

  Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

  
  

  The Senior Quality Assurance and Regulatory Affairs Analyst for Beckman Coulter Diagnostics is responsible for driving the Channel Partner Management process and managing Environmental Regulations (E-Waste, Plastic Waste, Battery Waste Management) for Southwest Asia. Additionally, will manage & support the Regulatory Affairs process for (ANZ) Australia and New Zealand. This position is part of the Quality Assurance and Regulatory Affairs located in New Delhi and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

  
  

  You will be a part of the Quality Assurance and Regulatory Affairs team and report to the Manager- Quality Assurance (SWA) responsible for Channel Partner Management, Environmental Regulations and Regulatory Affairs for ANZ. If you thrive in an amazing, multi country, multifunctional, multidomain role and want to work to build a world-class Quality Assurance and Regulatory Affairs organization—read on.

  
  

Job Responsibilities:

• Manage the due diligence screening process for new and existing distributors, including planning, gathering information, and collecting documents from CPs. Organize compliance and anti-corruption trainings for channel partners and track the completion of all mandatory trainings on a yearly basis.
• Track CP agreements and participate in the negotiation phase when appropriate. Establish and manage the CP compliance process for the entity and communicate compliance activities to Commercial and Senior Management.
• Establish a process for monitoring the expiry date of the drug licenses of our channel partners and ensure other compliances related to DL.
• Own the Environmental Regulations-related annual compliance activities for the organization and engage with CPCB for queries and resolutions pertaining to Environmental Regulations.
• Support the Australia Regulatory team with new product registrations and change notification submissions to TGA. Manage import Manufacturer Declarations, various permits and licenses applicable to the ANZ entity and Australia Post Market Surveillance (Adverse Events, recalls etc).

Job Requirements:

• Bachelor’s degree in science / pharmacy or related field with 5+ years of experience within the CP management process in medical devices or IVD industry OR Master’s degree in field with 3+ years of experience OR Doctoral degree in field with 0-2 years of experience.
• In-depth knowledge of Indian and ANZ regulatory requirements.
• Knowledge and experience for handling Environmental Regulations (Plastic Waste, E-waste and Battery Waste) for India.
• Experience in working in a matrix organization & International environment.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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