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Senior Quality Assurance And Regulatory Affairs Analyst

5+ years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Senior Quality Assurance and Regulatory Affairs Analyst
Location: Beckman Coulter Diagnostics, New Delhi, India


About Beckman Coulter Diagnostics

For more than 80 years, Beckman Coulter Diagnostics has been committed to advancing laboratory science to push healthcare forward. Our diverse and supportive team thrives on creating meaningful careers while celebrating unique backgrounds, experiences, and perspectives. Together with six other Danaher Diagnostics companies, we’re accelerating change to improve patient lives through innovative diagnostic tools.


Role Overview

We are seeking a Senior Quality Assurance and Regulatory Affairs Analyst to join our team and drive critical processes for Channel Partner Management and Environmental Regulations in Southwest Asia, as well as manage Regulatory Affairs for Australia and New Zealand (ANZ). This role is located in New Delhi and will be on-site.

As part of the Quality Assurance and Regulatory Affairs team, you will report to the Manager - Quality Assurance (SWA) and will be responsible for compliance management, product registration, and environmental regulations across multiple regions.


Key Responsibilities

  • Channel Partner (CP) Management:

    • Oversee the due diligence screening process for new and existing distributors.
    • Plan and collect necessary information and documents from channel partners.
    • Organize compliance and anti-corruption trainings and ensure completion of mandatory training annually.
    • Track CP agreements and support negotiations where necessary.
    • Establish and manage CP compliance processes and communicate updates to Commercial and Senior Management.
    • Monitor expiry dates of drug licenses and other compliance issues related to channel partners.
  • Environmental Regulations:

    • Manage annual compliance activities related to environmental regulations (e.g., plastic waste, e-waste, battery waste) for India.
    • Engage with the Central Pollution Control Board (CPCB) for any queries or issues related to environmental regulations.
  • Regulatory Affairs for ANZ:

    • Support the regulatory team in Australia with new product registrations and change notification submissions to the Therapeutic Goods Administration (TGA).
    • Manage import manufacturer declarations, relevant permits, licenses, and post-market surveillance activities such as adverse events and recalls in the ANZ region.

Required Qualifications

  • Education:

    • Bachelor’s degree in Science, Pharmacy, or a related field with 5+ years of experience in Channel Partner management within the medical device or IVD industry; OR
    • Master’s degree in a relevant field with 3+ years of experience; OR
    • Doctoral degree in a related field with 0-2 years of experience.
  • Experience:

    • In-depth knowledge of Indian and ANZ regulatory requirements.
    • Strong experience in managing Environmental Regulations (e.g., plastic waste, e-waste, and battery waste) in India.
    • Experience working in a matrix organization and an international environment.

Why Beckman Coulter Diagnostics?

Beckman Coulter Diagnostics is part of a global team that works tirelessly to improve patient care with diagnostic innovation. Join us to make an impact, be supported in your career growth, and enjoy a workplace where diversity, creativity, and new ideas thrive.


Apply Now

To learn more and apply, visit www.danaher.com.

Diversity and Inclusion

At Danaher, we believe in the strength of diversity and are committed to creating an inclusive environment where everyone can thrive. We are an equal opportunity employer and welcome diverse perspectives in our workforce.