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Regulatory Affairs Specialist (Medical Devices)

Boston Scientific · Almaty

Hybrid 🇬🇧 English

Job description

About the role

Boston Scientific is seeking a Regulatory Affairs Specialist to support product registrations and ensure regulatory compliance for its medical device portfolio in Kazakhstan. The role works closely with cross‑functional teams and local health authorities to bring innovative technologies to patients while upholding the company’s quality standards.

Key responsibilities

  • Plan, prepare and manage regulatory submissions and product registrations for assigned product lines.
  • Submit documentation to local health authorities and track approvals through completion.
  • Maintain existing product registrations and coordinate timely renewals.
  • Develop and sustain collaborative relationships with regulatory agencies, industry groups and internal stakeholders.
  • Provide accurate regulatory documentation for tender activities.
  • Act as a regulatory resource for cross‑functional teams, communicating changes in regulatory requirements.
  • Ensure compliance with Boston Scientific’s Quality System and promote patient safety and product quality.

Required profile

  • Bachelor’s degree in a scientific discipline or equivalent experience.
  • Several years of experience in regulatory affairs within a regulated industry.
  • Strong knowledge of medical device regulatory requirements and product registration processes.
  • Excellent communication, organization and problem‑solving abilities.
  • Ability to manage multiple priorities and work collaboratively across functions.

Required skills

    What we offer

    • Hybrid work model – minimum three days per week onsite in Almaty.
    • Access to the latest tools, information and training to advance your career.
    • Opportunity to contribute to innovative health solutions in a high‑performing, diverse environment.

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    Published 2 ай бұрын

    55 views · 0 interested

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    Boston Scientific

    Almaty