pThe Regulatory Affairs Manager is responsible for regulatory affairs deliverables related to the EU, US and Canada for product development, compliance projects, lifecycle management, and regulatory processes, for prosthetic and digital devices. The role also contributes to the responsible use of AI and automation to improve regulatory processes and operational efficiency. /p h3Main Responsibilities /h3 ul liManage the regulatory aspects of developing new prosthetic and digital devices. Develop and execute regulatory strategies and assemble high-quality deliverables for CE/UKCA marking, 510(k) and Health Canada submissions. /li liManage the regulatory compliance of prosthetic and digital devices throughout their lifecycle, including supporting change requests and sustaining projects; revising and updating technical files (STEDs and GSPRCs); handling claims; supporting post-market surveillance (PMS); and assessing risks for devices affected by HHEs, deviations, CAPAs or recalls. /li liSupport internal and external quality management system audits and technical file reviews, including audit preparation and front- and back-office support. /li liExecute and maintain product and economic operator registrations with authorities. Ensure accurate, timely and compliant UDI submissions and data integrity across relevant regulatory systems and jurisdictions. /li liSupport the creation and maintenance of regulatory procedures and processes; conduct country risk assessments; and gather regulatory intelligence to keep processes current and compliant with local regulations. /li liProvide regulatory guidance on global labeling and instructions for use (IFU), including eIFU, and support the maintenance of compliant content throughout the product lifecycle. /li liProvide regulatory guidance for software and connected digital solutions, including regulatory applicability, security risk management, post-market considerations and lifecycle changes. /li liIdentify practical AI and automation opportunities within Regulatory Affairs by analysing end-to-end processes and identifying steps suited to automation or AI while preserving human judgment. Assess feasibility, risks, controls and expected benefits; define appropriate governance and validation requirements. /li /ul h3Job Requirements /h3 ul liA minimum of a Bachelor's degree from accredited college or university is required. A Master's degree or PhD is of advantage. A degree focused on technology or science is preferred. /li liMinimum 5 years' experience in regulatory affairs within medical device industry. /li liMinimum 3 years' experience in working directly with authorities /li liIn depth knowledge of core aspects of EU, US and CA medical device regulations. /li liKnowledge of medical device quality management system requirements (ISO 13485). /li liKnowledge of core aspects of the design control process and the requirements for technical documentation for medical devices. /li liExperience of devising regulatory strategies and conducting impact assessments. /li liExperience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures. /li liWorking knowledge of software, cybersecurity risk management and post-market surveillance is an advantage. /li liFoundational knowledge of AI and automation concepts and the ability to support their responsible use in optimising Regulatory Affairs and Quality Assurance processes, with appropriate consideration of data quality, validation, human oversight and traceability. /li liFluency in English is a must. Further languages are an advantage. /li /ul pOperating company:Nobel Biocare /p pEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. /p #J-18808-Ljbffr
Regulatory Affairs Manager Arbeitgeber: Nobel Biocare
Nobel Biocare ist ein hervorragender Arbeitgeber, der seinen Praktikanten im Bereich Projektunterstützung die Möglichkeit bietet, wertvolle Erfahrungen in einem dynamischen und innovativen Umfeld zu sammeln. Mit einer starken Unternehmenskultur, die Teamarbeit und offene Kommunikation fördert, sowie umfangreichen Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung, ist dies der ideale Ort für Studierende, die ihre Fähigkeiten in der Dokumentenverwaltung und im Projektmanagement ausbauen möchten. Zudem profitieren Mitarbeiter von flexiblen Arbeitszeiten und einem internationalen Team, das Vielfalt schätzt und fördert.
