Regulatory Affairs Specialist

Detalles de la oferta

Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries ?PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas .Due to our constant growth, we are looking for aRegulatory Affairs Specialistto support our projects in our office inMadrid (Spain)You will be responsible for:Execution of new registrations for our various product lines; Definition of regulatorystrategies in compliance with the regulations of the countries where we operate; Coordination of activities related to the preparation of documents and regulatory submissions; Communication and collaboration with regulatory consulting firms to plan pre-submission approaches, compliance testing requirements, and follow-up of submissions to ensure regulatory compliance; Compilation and maintenance of regulatory databases or documentation systems; Support for local regulatory teams and internal departments; Monitoring and interpretation of regulatory standards and their changes, to ensure correct communication through company policies and procedures; Support for regulatory inspections.First Client's project you will be assigned to:Location:Alcobendas, Madrid100% onsite (flexible)Duration of this first project: 10 months (We offer apermanent contract )About you2-5 years of experience in the regulatory field, preferably in multinational or structured companies producing medical devices or pharmaceuticals; Bachelor's or Master's degree, preferably in a scientific field; Familiarity with the European and international regulatory framework (MDR, FDA Quality System Regulations, MDSAP); English language proficiency in speaking and writing (at least B2 level)Proficiency in the Office suite (knowledge of SAP would be a plus); Excellent analytical skills and ability to work in a team.Next StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.If there's a positive match, a technical interview with the Hiring Manager will be arranged.In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of achallenging, multicultural company that values collaboration and innovation.
PQE Group gives you theopportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for arewarding and exciting career, PQE Group is the perfect place for you.Apply now and take the first step towards an amazing future with


Salario Nominal: A convenir

Fuente: Talent_Ppc

Requisitos

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