Temat tygodnia
O pandemii, wyzwaniach, zmianach i rekrutacji w Centrum Kompetencji Księgowych w Schneider Electric Polska.
Trwa ładowanie. Prosimy o chwilę cierpliwości.
Goldman Recruitment
Data aktualizacji: 2021-05-02
Warszawa, mazowieckie
BPO/SSC
Data aktualizacji: 2021-05-02 Aplikuj
REKRUTACJA ZDALNA
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.

www.goldmanrecruitment.pl

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


Regulatory Affairs Specialist
Regulatory Affairs Specialist
Work place: Warszawa
Ref. no 192164/6901

Opis stanowiska:
  • working closely with regional, country, global cross-functional teams,
  • communicating and executes regulatory strategies and plans, supporting the development of country/regional positions on regulatory risk-benefit, supporting project teams to ensure regulatory requirements are incorporated and met throughout the product life cycle,
  • providing support in obtaining documentation for registration dossiers and responses to queries from the regulatory authorities,
  • preparing registration dossiers (new, renewals, re-registrations) and response to queries from the regulatory authorities, reviewing registration dossiers prepared by Consultants, Regulatory Associates/Specialists,
  • assisting with data entry, maintenance of regulatory files, and tracking databases to ensure availability of accurate company regulatory information, supporting the maintenance of registration license data for distribution control,
  • participation in internal/external audit activities, coordinating audit corrective actions.
  • supporting reimbursements, tenders, government notifications, regulatory approvals, site certifications, Quality field actions, PMS, audits/inspections,
  • understanding and influences the medical device regulatory environment by leveraging relationships with regulatory authorities and industry groups. Participation in industry working groups.
  • interpreting and applying regulations to business practices and provides regulatory input, advice, and guidance to the organization which may affect the registration approval of products, post-market activities, and processes.
  • responsibility for regulatory compliance (e.g., establishing Companys policies/procedures and ensuring compliance to them, supporting review of advertising and promotional materials for compliance to local requirements).
Wymagania:
  • Bachelor’s Degree in life sciences, technical (engineering), or related field,
  • minimum of 3 years of experience required in a Regulatory Affairs or equivalent experience 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.
Oferta obejmuje:
  • possibility to take part in the building of a new GBS in Warsaw from the medical industry,
  • competitive benefits package, bonus system,
  • meal vouchers,
  • medical care,
  • holiday supplement,
  • pension plan.