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Goldman Recruitment
Data aktualizacji: 2021-02-22
Warszawa, mazowieckie
Data aktualizacji: 2021-02-22 Aplikuj
Goldman Recruitment is a leading Polish consulting company specializing in recruitment using Search & Selection and Executive Search methods. Our ambition is to provide the highest level of service, ahead of the market and creating a new standard in the personal consulting industry.

For our Client - a medical company, we are currently looking for Regulatory Affairs Manager to join the new GBS in Warsaw.

Regulatory Affairs Manager
Regulatory Affairs Manager
Work place: Warszawa
Ref. no 192165/6902

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.
  • 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.