Regulatory Affairs Specialist
HybridKazakhstan, Ulytau Region, Republic of Kazakhstan
Job Summary
Plan and manage regulatory submissions and product registrations for assigned medical device lines, preparing documentation for local health authorities while monitoring approvals. Maintain product registrations and ensure timely renewals, supporting tender activities with accurate regulatory data. Build collaborative relationships with regulatory agencies, industry groups, and internal stakeholders to serve as a regulatory resource for cross-functional teams. Monitor changing regulatory requirements and ensure compliance with the Boston Scientific Quality System. This hybrid role requires three days in the Almaty office weekly.
Required Qualifications
- Bachelor's degree in a scientific discipline or equivalent experience
- Minimum of several years' experience in regulatory affairs within a regulated industry
- Knowledge of medical device regulatory requirements and product registration processes
- Strong communication, organization and problem-solving skills
- Ability to manage multiple priorities and collaborate effectively across functions
Desired Qualifications
- Experience in the medical device industry
- Experience working directly with health authorities and cross-functional teams
- Knowledge of local regulatory requirements and submission processes
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