Senior Quality Assurance and Regulatory Affairs Analyst
Senior Quality Assurance and Regulatory Affairs Analyst
Posted on :
05-02-2025
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1 Vacancy
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Job Description
Job Title: Senior Quality Assurance and Regulatory Affairs Analyst
Job Location: Delhi India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
- Wondering what’s within Beckman Coulter Diagnostics Take a closer look.
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 (EWaste 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 onsite. 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 worldclass 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 anticorruption 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 Regulationsrelated 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).
- 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 02 years of experience.
- Indepth knowledge of Indian and ANZ regulatory requirements.
- Knowledge and experience for handling Environmental Regulations (Plastic Waste Ewaste and Battery Waste) for India.
- Experience in working in a matrix organization & International environment.
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At Danaher we value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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Employment Type
Full Time
Key Skills
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