Job Opportunities API

Bei Medtronic kannst Du eine Karriere für Dein Leben starten. Und Dich für ein gerechtes und innovatives Gesundheitswesen einsetzen, das für alle zugänglich ist. Du wirst zielstrebig Barrieren abbauen, die Innovationen in einer stärker vernetzten und solidarischen Welt im Wege stehen. Ein Tag im Leben Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections Responsibilities may include the following and other duties may be assigned: • Set up new process for entering new data - Regulatory Information Management System. • Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes. • Keeps abreast of regulatory procedures and changes. • Provide requested regulatory data and documents to support tenders • Keeps abreast of regulatory procedures and changes. • Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information. • Prepare, review, file, and support premarket documents for global registrations for assigned projects. • Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. • Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections. • Compiles all materials required in submissions, license renewal and annual registrations. • Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance. • Monitors and improves tracking/control systems. • May direct interaction with regulatory agencies on defined matters. • Develop Regulatory Strategies for new or modified products for assigned projects. • Monitor and provide information pertaining to impact of changes in the regulatory environment. • Communicate with regulatory agencies and/or notify bodies on administrative and routine matters. • Document, consolidate, and maintain oral and written communication with health authorities. • Prepare internal documents for modifications to devices, when appropriate. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. Required knowledge and experience: • Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors. • 7+ year’s experience for RA role in medical device and or pharmaceutical industry. • Works independently with general supervision on larger, moderately complex projects / assignments. • Contributes to the completion of project milestones. • Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. • Ability to quickly establish credibility with all levels of customer base. • Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making. Nice To Have Skills: • Excellent communication and interpersonal skills. • Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. • Self-motivated and positive. • Ability to quickly establish credibility with all levels of customer base. Physische Jobanforderungen Die obigen Aussagen sollen die allgemeine Art und den Umfang der Tätigkeit beschreiben, die von den Mitarbeitern in der jeweiligen Position ausgeführt wird. Sie enthalten jedoch nicht alle für diese Position erforderlichen Verantwortlichkeiten und Fähigkeiten. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected] . Leistungen und Vergütung Medtronic bietet ein wettbewerbsfähiges Gehalt und ein flexibles Leistungspaket Das Engagement für unsere Mitarbeiter ist der Kern unserer Werte. Wir schätzen die Beiträge jedes einzelnen. Sie tragen damit zu unserem Erfolg bei.   Wir bieten für jede Karriere- und Lebensphase umfassende Leistungen, Ressourcen und wettbewerbsfähige Vergütungspläne. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).