Medtronic
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Lausanne
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
INIntuitive
Regulatory Affairs Specialist(m/w/x)
Aubonne
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Supporting EMEA product registrations and CE marking for robotic surgery devices. 3-5 years medical device regulatory affairs experience required. EUDAMED and Swissdamed system implementation.
Anforderungen
- 3-5 years regulatory affairs experience in medical devices (EU regulations)
- Bachelor's degree in Engineering, Medical Technology, or related field, or relevant experience
- Solid knowledge of global medical device regulations (ISO 13485, EU MDR)
- Experience with regulatory activities (sustaining, remediation, registration, labeling, CAPA, audit readiness)
- Familiarity with EU compliance directives (RED, ROHS, Waste Framework Directive)
- Strong organizational and planning abilities, proactive, results-driven
- Excellent interpersonal skills for international/cross-department collaboration
- High attention to detail for accuracy and completeness
- Proficient English (minimum C1 level)
- Skilled with Microsoft Office and Outlook
- Able to work on-site in Aubonne, Switzerland
- Familiarity with EUDAMED, Swissdamed, or similar structured regulatory systems
- Experience with labeling or IFU remediation, language requirement assessments, or electronic IFU implementation
- Experience supporting registration lifecycle maintenance, distributor documentation, or market documentation readiness
- Experience with Smartsheet, Power BI, Jira, or similar tracking/dashboard tools
- Exposure to clinical trial support activities in medical device environment
Aufgaben
- Support registration activities across EMEA
- Assist with CE marking for products
- Handle non-medical product registrations
- Support local registration processes
- Implement EUDAMED and Swissdamed systems
- Collect and verify data for EUDAMED and Swissdamed
- Update trackers for EUDAMED and Swissdamed
- Follow up with stakeholders on EUDAMED and Swissdamed
- Support compliance activities
- Manage CAPA processes
- Follow up on audit findings
- Prepare for inspections
- Maintain RA documentation
- Support RA operational tasks
- Manage labeling and eIFU processes
- Develop and maintain RA procedures
- Update trackers and dashboards
- Drive continuous improvement initiatives
- Provide timely regulatory input to internal stakeholders
- Coordinate follow-up actions for internal stakeholders
- Support Quality Management System activities
- Maintain controlled documentation
- Support cross-functional teams within RA scope
- Execute additional regulatory tasks and projects as assigned
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- Directive 93/42/EEC
- Regulation 2017/745/EU
- RED
- ROHS
- Waste Framework Directive
- EUDAMED
- Swissdamed
- Smartsheet
- Power BI
- Jira
- Microsoft Office
- Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Intuitive erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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INIntuitive
Regulatory Affairs Specialist(m/w/x)
Aubonne
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Supporting EMEA product registrations and CE marking for robotic surgery devices. 3-5 years medical device regulatory affairs experience required. EUDAMED and Swissdamed system implementation.
Anforderungen
- 3-5 years regulatory affairs experience in medical devices (EU regulations)
- Bachelor's degree in Engineering, Medical Technology, or related field, or relevant experience
- Solid knowledge of global medical device regulations (ISO 13485, EU MDR)
- Experience with regulatory activities (sustaining, remediation, registration, labeling, CAPA, audit readiness)
- Familiarity with EU compliance directives (RED, ROHS, Waste Framework Directive)
- Strong organizational and planning abilities, proactive, results-driven
- Excellent interpersonal skills for international/cross-department collaboration
- High attention to detail for accuracy and completeness
- Proficient English (minimum C1 level)
- Skilled with Microsoft Office and Outlook
- Able to work on-site in Aubonne, Switzerland
- Familiarity with EUDAMED, Swissdamed, or similar structured regulatory systems
- Experience with labeling or IFU remediation, language requirement assessments, or electronic IFU implementation
- Experience supporting registration lifecycle maintenance, distributor documentation, or market documentation readiness
- Experience with Smartsheet, Power BI, Jira, or similar tracking/dashboard tools
- Exposure to clinical trial support activities in medical device environment
Aufgaben
- Support registration activities across EMEA
- Assist with CE marking for products
- Handle non-medical product registrations
- Support local registration processes
- Implement EUDAMED and Swissdamed systems
- Collect and verify data for EUDAMED and Swissdamed
- Update trackers for EUDAMED and Swissdamed
- Follow up with stakeholders on EUDAMED and Swissdamed
- Support compliance activities
- Manage CAPA processes
- Follow up on audit findings
- Prepare for inspections
- Maintain RA documentation
- Support RA operational tasks
- Manage labeling and eIFU processes
- Develop and maintain RA procedures
- Update trackers and dashboards
- Drive continuous improvement initiatives
- Provide timely regulatory input to internal stakeholders
- Coordinate follow-up actions for internal stakeholders
- Support Quality Management System activities
- Maintain controlled documentation
- Support cross-functional teams within RA scope
- Execute additional regulatory tasks and projects as assigned
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- Directive 93/42/EEC
- Regulation 2017/745/EU
- RED
- ROHS
- Waste Framework Directive
- EUDAMED
- Swissdamed
- Smartsheet
- Power BI
- Jira
- Microsoft Office
- Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Intuitive erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Intuitive
Branche
Healthcare
Beschreibung
The company is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care.
Noch nicht perfekt?
- Medtronic
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - SHQ Medtronic Int. Trading Sàrl
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - Haemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSigny-Avenex - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
VollzeitPraktikumnur vor OrtEysinsab CHF 60.000 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 144.000 / Jahr