Regulatory Affairs Officer – Poznań Sady, Tarnowo Podgórne

Miejsce pracy: Wielkopolskie / Poznań, Sady – gmina Tarnowo Podgórne

LiNA Medical Polska Sp. z o.o. – producent urządzeń medycznych w obszarze ginekologii małoinwazyjnej poszukuje pracownika na stanowisko: Regulatory Affairs Officer.

Status Oferty Pracy: Aktualna
Dział: RA
Rodzaj pracy: Pełen etat

Main responsibilities:

  • Supporting the Post-Market Surveillance (PMS) process – creating, investigating, monitoring and maintaining;
  • Provide regulatory support for clinical evaluation process;
  • Manage product registrations and renewals on selected markets;
  • Lead and drive regulatory activities in accordance with local and international requirements;
  • Responsible for review and update of regulatory documents, product technical files and for ongoing activities related to compliance with regulatory directives and regulations;
  • Conduct reviews of product and manufacturing changes for compliance with applicable regulations; Review and approve Change Requests in accordance with regulatory requirements;
  • Communicate with and maintain a positive business relationship with external customers from distributors to health authorities (FDA, Health Canada, Notified Body);
  • Drive improvement in regulatory aspects of the Quality Management System and in documenting procedures to ensure an effective Quality System is maintained;
  • Assistance with audits;
  • Act as a Project Leader in diverse internal projects;
  • Contribute to providing regulatory advice throughout the product lifecycle;
  • Perform other tasks or assignments, as delegated by regulatory management.

Requirements:

  • Master degree in life science / Technical discipline or relevant;
  • Minimum 3+years regulatory experience in the Medical Device or Pharmaceutical industry;
  • Previous experience working with Regulatory Authorities;
  • Experience in registration of medical devices or pharmaceuticals in EEA and outside European Union;
  • Familiar with MDD 93/42/EEC, MDR 2017/745, EN ISO 13485;
  • Knowledge of standards and quality systems;
  • Experience in auditing is an advantage;
  • Excellent verbal and written communication skills with ability to effectively communicate at multiply levels in the organization;
  • Ability to prioritize and plan work activities in a fast-paced environment; adapt for changing conditions;
  • Good interpersonal skills – ability to work both independently and as part of a team;
  • Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision;
  • Attention to details, quality and accuracy;
  • Effective analytical/problem solving skills;
  • Fluent in English (oral and written);
  • Ability to analyse and resolve non-routine regulatory issues using independent judgment.
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