PAre you ready to join a bworld leader /b in the exciting and dynamic fields of theb Pharmaceutical and Medical Device industries? PQE Group /b has been at the forefront of these industries bsince 1998 /b, with b40 subsidiaries /b and more than b2000 employees in Europe, Asia and the Americas. /b /ppbr/ppAs part of our ongoing growth and commitment to excellence, we are currently looking for a bMedical Device Compliance Senior Consultant /bto join our international team in bBarcelona /b. This is a unique opportunity to contribute to high-impact projects, working alongside top-tier professionals in an innovative and fast-paced environment. /ppbr/ppResponsibilities include, but are not limited to: /pullibParticipate in multiple projects /b in the bmedical devices sector /b, ensuring btimely delivery /b and adherence to bproject budget /b and bcustomer needs /b /lilibSupport QA and RA activities /b at Medical Device Companies /lilibEnsure compliance /b with bregulatory requirements /b and bquality standards /b (e.g., bFDA /b, bISO 13485 /b, bMDR /b, and bIVDR /b) /lilibEstablish, implement, review and update QMS procedures /b /lilibImplement CAPA process /b /liliParticipate in activities on bRisk Management File /b /lilibDevelop process validation protocols (IQ-OQ-PQ) /b and bwrite summary reports /b /liliSupport bregulatory activities for CE marking /b, bMDR or IVDR certification /b (design and development activities, review of labelling materials, technical documentation preparation) /liliSupport bClinical Evaluation /b, bPost Market Surveillance /b, bPost Market Clinical Follow-Up /b /liliSupport bcomplaints investigation /b and report completion, including bcybersecurity issues /b from post-market /liliSupport bextra-EU registration /b /lilibCoordinate and collaborate with cross-functional teams /b, including bManagement, Operations, and Sales Team /b /li /ulpbr/ppRequired Qualifications: /pullib3+ years of experience /b in similar roles in the Medical Device field, with expertise in bQuality Assurance /b and/or bRegulatory Affairs of MD Industry /b /liliKnowledge of binternational and local MD regulations /b /liliUnderstanding of bQuality Management System requirements, Risk management principles, Regulatory requirements /band bindustry best practices /b /liliFamiliarity with bISO 14971 /b, bProduct Risk Management /b and bRisk Analysis techniques /b /lilibVV requirements /b /liliExperience with bpost-market surveillance /b /liliTechnical skills related to bmedical device industry processes /b /liliStrong banalytical skills /b and ability to work in a bstructured and concise manner /b /liliEffective bwritten and verbal communication in English /b /li /ulpbr/ppbNext Steps /b /ppUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. /ppIf there's a positive match, a technical interview with the Hiring Manager will be arranged. /ppIn the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. /ppAlternatively, if the outcome is negative, we will contact you to halt the recruitment process. /ppbr/ppbWorking at PQE Group /b /ppAs a member of the PQE team, you will be part of a bchallenging, multicultural company that values collaboration and innovation /b. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. /ppIf you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. /ppApply now and take the first step towards an amazing future with us. /p