Quality & Regulatory Affairs Specialist (Portuguese Market) at Zimmer Biomet | Torre
Quality & Regulatory Affairs Specialist (Portuguese Market)
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Zimmer Biomet

Quality & Regulatory Affairs Specialist (Portuguese Market)

Zimmer Biomet
Emma
Emma
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Full-time

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Barcelona, Spain
Shared by
Julien PETIT
 3 months ago

Responsibilities

As a QARA Specialist, you will be part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization.You will be responsible for supporting the Quality Assurance & Regulatory Affairs function of Portugal by:ensuring compliance with the requirements of ISO 13485 Quality Management System, appropriate company policies and any other ISO if applicable or required in country (i.e ISO9001, ISO14001, ISO37001 e.t.c).ensuring local organization comply with industry specifications, standards and European as also in country regulations (i.e European Medical Device Regulation (EU) 2017/745).How You'll Create ImpactQuality Management System (QMS)Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System)Drive CAPAs and Issue EvaluationsParticipate, provide support and manage quality reviewsSupport with QA/RA standardization of processesWork on continuous improvement of our processesRegulatory ComplianceBe responsible for product registration, notifications, or renewals and/or regulatory clearance in assigned market in accordance with local in-country regulatory requirementsBe main contact for the local competent authority. Act as a local regulatory responsible personProvide regulatory support to commercial and in-country local commercial teamsManage and maintain regulatory documentation, ensuring it complies with applicable regulatory standards and guidelinesAssist with effective, consistent, and reliable Product SurveillanceComplaint HandlingBe responsible for complaint handling (submission, coordination of product return, follow-up investigation)Field Actions (Recalls)Liaise with FSCA team and regional stakeholders to initiate recallsHandling the Field Safety Notices to the affected customers, reports the reconciliation of products and customers acknowledgment to the PMS team or FSCA TeamBe responsible for the handling of instructed actions like Field Notices (FN), Product HoldsAudits internal/ externalPlan, support and join the internal and external auditsEnsure the Audit preparation activities and support for auditees. Ensure follow-up on Audits (Internal/EMEA/External) as appropriate and required by the internal proceduresWhat Makes You Stand OutAbility to handle high volume of correspondence and prioritize work accordinglyAbility to work independently and collaboratively in a team-oriented environment.Ability to prepare high quality, clear communication materials to the appropriate audienceExcellent communication and interpersonal skills.Ability to work with accuracy and precision.Diplomacy and tenacity.Discretion and confidentialityAbility to work in a multinational team.Ability to adapt to changing environment.Your BackgroundYou hold a B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science (or equivalent experience) alongside with 5+ years’ experience in registration/notification activities and/or quality assurance in medical devices area.You have a comprehensive knowledge of regulatory requirements and legislation in Portugal.In addition you are fluent in Portuguese, Spanish and English.Travel ExpectationsUp to 5%.
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