Regulatory Affairs Specialist

з/п не указана

Требуемый опыт работы: не требуется

Полная занятость, полный день

ABBOTT is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

We are looking for Regulatory Affairs Specialist in Minsk, contractor position.

Office in Minsk, Abbott Laboratories GmbH Representative Office in Minsk
1st Zagorodnyj lane, 20 (office 1503)

Purpose of The Job:

  • The main purpose of this job is the assist the EMEA Regulatory Affairs Department with the management of changes arising from CE marking of Abbott Business Unit medical devices due to the implementation of the European Medical Devices Regulation (“MDR”).
  • This role will assist by providing regulatory and quality documentation to the respective EMEA Regulatory Authorities in the region to support variations and changes to existing product registration approvals.

Main Responsibilities:

  • Prepare and submit regulatory files and documentation to Regulatory Authorities in accordance with local country regulatory requirements;
  • Support products changes and impacts resulting from the EU MDR, including but not limited to re-branding, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required;
  • Support and assist the local EMEA RA / Regional Manager to implement to ensure no business interruption arising from the implementation of the EU MDR;
  • Liaise with the International RA Department staff. Implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to;
  • Provide metrics and feedback to management as required to enable tracking of regulatory activities in support of MDR impact analyses and implementation in EMEA;
  • Support the local Commercial Organization and EMEA RA by submitting documentation needed to meet local requirements;
  • Work with Business Unit RA colleagues, EMEA RA Managers, and EU MDR Project Leaders to obtain required documentation arising from CE marking of medical devices under the EU MDR;
  • Liaise with the Abbott Business Unit Regulatory Affairs / Quality Assurance / Regulatory Compliance Departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements.

Main Requirements:

  • University Degree or last year student (medicine, pharmacy, chemistry, biology);
  • 1+ year of experience of working in a regulated environment, preferably in medical devices is required;
  • Some experience or knowledge of compliance activities, adherence to quality management systems requirements and product registration activities is desirable;
  • Knowledge of the application of regulations relevant to the Medical Device Industry;
  • Experienced MS Office user (Excel);
  • Strong knowledge of Russian and English languages;
  • Good communication skills, critical thinking and ability to challenge;
  • Strong attention to detail, highly organized, efficient and ability to meet deadlines;
  • Team player with ability to work independently, flexible to cope with varying workload and demands as required;
  • Able to work with integrity and in compliance with internal company policies and external regulatory requirements.

We offer:

  • Possibility of professional development;
  • Interesting work in the multinational company.

If you are interested in this opportunity, please do not hesitate to reach out and apply with your CV.

Ключевые навыки

Английский — C1 — Продвинутый
Budgeting
Project management
Marketing Analysis
Leadership Skills

Вакансия опубликована 9 мая 2021 в Минске

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