Manager Quality and Regulatory Assurance

3 weeks ago

Hyderabad, Telangana, India Omicsveu Full time

Manager Quality and Regulatory Assurance

Location: Adibatla, Hyderabad

OmicsVeu, a pioneer in precision oncology, is seeking a passionate and dedicated Regulatory Affairs & Quality Assurance (RA/QA) Manager for our India operations. This critical role will drive regulatory excellence, uphold the highest quality standards, and accelerate our mission to transform cancer diagnostics using cutting-edge spatial biology and multi-omics technologies.

Key Responsibilities:

  • Lead and manage regulatory submissions, ensuring compliance for diagnostic and medical device products.
  • Develop, implement, and maintain comprehensive quality assurance processes aligned with international standards.
  • Collaborate effectively with cross-functional teams to ensure product integrity, safety, and clinical efficacy.

Qualifications:

  • Minimum of 5 years' QA/RA experience with proven track record in Regulatory Affairs and Quality Assurance within the diagnostics or medical devices industry.
  • Deep knowledge of regulatory requirements including ISO 13485, FDA regulations, and CE Marking.
  • Strong organizational, analytical, problem-solving, and communication skills.
  • Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.
  • Expert knowledge of ISO 13485, US FDA QMSR, EU IVDR, Health Canada, and other international regulations.
  • Proven experience in global product registration and distributor support preferred.
  • Demonstrated capability managing regulatory audits and inspections.
  • Strong analytical, organizational, and interpersonal communication skills.
  • Ability to effectively collaborate across global teams and time zones.

Why OmicsVeu?

Join a dynamic team committed to democratizing precision oncology and improving patient outcomes globally. Be part of an innovative environment where your contributions directly impact advancements in cancer care.

Apply today and be a part of the OmicsVeu revolution.

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