Haemonetics S.A.
Regulatory Affairs Specialist (m/w/x)
VollzeitBefristeter Vertragmit HomeofficeJunior
Signy-Avenex
INIntuitive
Regulatory Compliance Commercial Specialist (m/w/x)
VollzeitBefristeter Vertragmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Ensuring compliance with EU MDR and Swiss MedDO for robotic-assisted surgery devices. 4+ years medical device industry experience required. Hybrid work, 5-person regulatory team.
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Anforderungen
- 4+ years medical device industry experience (US/EU regulation)
- 3+ years medical device quality system management, manufacturing, or regulatory affairs
- Bachelor's degree in medical technology, life sciences, or similar
- Master's degree in medical technology, life sciences, or similar
- Equivalent work experience in similar function
- Strong knowledge of EU MDR 2017/745/EU
- Strong knowledge of ISO 13485:2016
- Ability to work autonomously
- Daily judgment based on regulatory knowledge
- Demonstrated organizational skills
- Demonstrated planning skills
- Action oriented and can-do attitude
- Focused urgency
- Driving for results
- Excellent verbal communication skills
- Excellent written communication skills
- Excellent presentation skills
- Ability to distill complexity
- Provide clear and actionable direction
- Orientation for work result details
- Emphasis on accuracy
- Emphasis on completeness
- Computer literacy
- Microsoft Word proficiency
- Microsoft Excel proficiency
- Microsoft PowerPoint proficiency
- Microsoft Outlook proficiency
- Fluent English
- Fluent French
- Lead auditor certification for ISO 13485
- Knowledge of WW regulations
Aufgaben
- Coordinate and ensure timely execution and consistency of compliance activities
- Act as a subject-matter contributor
- Ensure regulatory compliance
- Advise commercial teams
- Ensure compliance with EU MDR, Swiss MedDO, and regulatory frameworks
- Manage customer regulatory inquiries and tender support
- Perform product compliance verification and document regulatory assessments
- Support review of commercial communications
- Manage Economic Operator notifications and escalation to manufacturer
- Perform regulatory surveillance, impact assessments, and stakeholder communication
- Support site KPIs and management review inputs
- Support audits and inspections
- Act as Technical Manager
- Own local compliance processes
- Maintain Economic Operator records and registrations
- Support Quality Agreement execution, implementation, and tracking
- Execute EU commercial QMS activities, including procedures, support, and audits
- Ensure timely closure and documentation of compliance activities
- Lead regulatory activities for product lifecycle
- Act as RAQA binôme for commercial functions
- Support training center management
- Participate in field activities to identify compliance gaps
- Support customer relationship management and issue resolution
Berufserfahrung
4 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – fließend
Französisch – fließend
Tools & Technologien
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Von Nejo automatisch aufbereitet
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.
Zur Originalanzeige bei IntuitiveÜber das Unternehmen
IN
HealthcareAubonne
The company is a pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care.
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