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