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: Nieaktualna
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.
