Regulatory Affairs Officer

at  LiNA Medical Polska

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

KNOWLEDGE/EXPERIENCE:

• 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.

SKILLS:

• 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.

• 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;
• Supporting the Post-Market Surveillance (PMS) process – creating, investigating, monitoring and maintaining;
• Provide regulatory support for clinical evaluation process.