Специалист по регистрации и качеству

Regulatory Affairs & Quality Assurance Specialist

№44396

Медицинское оборудование

Москва, Россия

Регулирование

Временная занятость

Откликнуться
Leading multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology, and surgical specialties is looking for a candidate for a posiion of regualtory affairs and quality assurance specialist.

Обязанности

  • Obtain product registration dossiers from Divisions and tailor them to meet country registration requirements. Prepare and submit applications to Ministry of Health.
  • Prepare and submit applications to Social Security Institute for getting reimbursement approvals.
  • Support the international team, e.g., by executing regulatory strategies and registration timelines; by monitoring and communicating regulatory intelligence and assessing its potential impact; by assuring that product to be registered meets country regulatory requirements.
  • Coordinate communication among divisions, International Business Centres, dealers, and health authorities in support of gaining regulatory approvals. 
  • Develop proper working relationships with Ministry of Health. 
  • Assess proposed changes to registered products for their impact on product registration and importation.
  • Support post-market activities including product registration renewals, complaint reporting, and field actions.
  • Maintain records and tracking of registrations, registration activity and quality activities.
  • Support health authority inspections.
  • Work with Divisions and IBCs to provide quality and regulatory direction for customer complaint management and adverse event reporting, in accordance with corporate and local requirements. 
  • In collaboration with Divisions, and in conformance to Corporate Regulatory and Quality requirements, develop strategies for implementing field actions, e.g., product recalls, withdrawals, safety alerts.
  • Implement a Quality System compliant to corporate and local requirements.

Требования

  • Demonstrated knowledge of product registration requirements in international markets (Russia).
  • Solution and results-oriented.
  • Must have technical and project management skills.
  • Must have technical writing skills and be proficient at compiling successful submissions.
  • Ability to work with all levels of management and across functions.
  • Basic knowledge of Quality systems and management in a regulated industry.
  • Excellent English communication skills; written and verbal.

Примечание

Поскольку каждый день мы получаем большое количество откликов, к сожалению,у нас есть возможность связаться только с кандидатами, чей профиль максимально соответствует требованиям вакансии. Получить ответ возможно в течение двух недель. Желаем успеха в поиске новой работы!