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Dla pracownika

Oferta pracy

Regulatory Affairs Manager

Nr ref. 192165/6902
For our Client - a medical company, we are currently looking for Regulatory Affairs Manager to join the new GBS in Warsaw.
Warszawa (mazowieckie)
Lokalizacja
Centra usług wspólnych
Specjalizacja
Kierownik
Poziom stanowiska
stała
Rodzaj umowy
angielski
Wymagany język
Izabela Suchocka
Konsultant

Opis stanowiska:

  • working closely with regional, country, global cross-functional teams,
  • managing projects to communicate and execute regulatory strategies and plans,
  • supporting the development of country/regional positions on regulatory risk-benefit and project teams to ensure regulatory requirements are incorporated and met throughout the product life cycle,
  • action as a liaison with various functional, regional, and global teams,
  • providing support in obtaining documentation for registration dossiers and responses to queries from the regulatory authorities,
  • overseeing the preparation of registration dossiers (new, renewals, re-registrations) and responses to queries from the regulatory authorities,
  • reviewing registration dossiers prepared by Consultants, Regulatory Associates/Specialists,
  • managing data entry, maintenance of regulatory files, and tracking databases to ensure availability of accurate company regulatory information, ensuring maintenance of registration license data for distribution control,
  • planning and manages internal/external audit activities; coordinating audit corrective actions,
  • leading/supporting reimbursements, tenders, government notifications, regulatory approvals, site certifications, Quality field actions, PMS, audits/inspections, etc.,
  • managing the team’s training, mentoring, and professional development. Managing budget and resources. Responsibility for oversight and prioritization of assigned projects. Leading continuous improvement activities.

Wymagania:

  • Bachelor’s Degree in life sciences, technical (engineering), or related field,
  • minimum of 3 years of experience as a Regulatory Affairs Manager in the medical device industry,
  • working knowledge and experience applying medical device regulations, standards, and guidance documents,
  • English language skills (C1), another languages skills - will be an advantage,
  • ability to communicate effectively at multiple levels, including with regulatory authorities,
  • knowledge of medical device products, regulations, standards; ability to interpret and apply them,
  • ability to manage multiple projects,
  • strong problem-solving competencies,
  • readiness for business trips (20%).

Oferta obejmuje:

  • possibility to take part in the building of a new GBS in Warsaw from the medical industry,
  • competitive benefits package, bonus system, company car,
  • meal vouchers,
  • medical care,
  • holiday supplement,
  • pension plan.
Aplikacja
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