Regulatory Manager

2 settimane fa

Italia SGS A tempo pieno

OverviewWe are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity and the delivery of high-quality assessments aligned with MDR and IVDR. Your MissionAs Regulatory Manager you will : Serve as the primary contact for regulatory matters including communication with designating authorities, notified bodies (NB), UK Approved Bodies (UKAB), competent authorities, the Commission and other external regulatory stakeholders. Act as the regulatory ambassador for various Medical Schemes and the main liaison to Team NB. Manage all regulatory processes to ensure full compliance across all Medical Schemes. Ensure all contractual agreements including those with inter-office and subcontractors are current, compliant and properly maintained. Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance and best practices. Support line managers in conducting annual risk analyses to confirm the impartiality and independence of Notified Body staff. Plan, organise and implement relevant regulatory training programs. Ensure the SGS Medical website remains current and accurate in terms of regulatory content. QualificationsEducation : Advanced degree in a clinically relevant field; additional training in medical device clinical evaluation and performance studies would be a strong advantage. Experience and skills : Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR). Strong ability to work with senior management, technical, marketing, sales and administrative personnel at a corporate, regional and delivering office level. Ability to represent SGS to medical device regulatory authorities and other external fora. Excellent interpersonal and communication skills including fluency in English (a must have). Negotiation and persuasion skills. Change Management skills. Strong organisational skills and flexibility. 5 years experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have). 10 years experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry. Keen eye for detail and is focused on delivering results within agreed timeframes. Operates ethically with the highest degree of professional integrity. Please kindly send your CV in English Additional InformationWhy SGS Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry. Flexible schedule and hybrid model. SGS university and Campus for continuous learning options. Multinational environment where you will work with colleagues from multiple continents. Benefits platform. Join Us : At SGS we believe in innovation, collaboration and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development. Remote Work : Employment Type: Full-time Key SkillsProofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills Experienceyears Vacancy1 #J-18808-Ljbffr

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