Strefa Klienta
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.
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.
Powiadomienie - oferty pracy
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