Citrus Global
IT Systems Compliance Manager – Engineering(m/w/x)
Vollzeit
Senior
Keine Angabe
Frankfurt am Main
AB
Abbott Medical GmbH2 Monate
Senior Manager, Regulatory Compliance(m/w/x)
Vollzeit
Senior
Keine Angabe
65760 Eschborn
Nejo KI-Zusammenfassung
In this role, you will oversee regulatory compliance for the Cardiovascular & Neuromodulation business units across EMEA, ensuring adherence to regulations while fostering strong relationships with regulatory authorities. Your day-to-day responsibilities will include developing quality systems, managing compliance activities, and supporting inspections, all while guiding and developing your team.
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Anforderungen
- •University degree in sciences or related discipline
- •7+ years of related work experience in a regulated industry
- •Proven track record in a leadership role
- •Proficiency with MS Office (Word, Excel, Outlook)
- •Strong verbal and written communication skills
- •Willingness to travel up to 30%
- •Advanced degree in Engineering, Sciences, or related discipline
- •Medical device experience
- •Experience collaborating with cross-functional teams
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
7 Jahre
Deine Aufgaben
- •Manage the compliance function for Cardiovascular & Neuromodulation business units in EMEA
- •Develop and implement processes and staffing to maintain the quality system
- •Establish strategic vision and goals aligned with site organization and business units
- •Ensure compliance with internal requirements and external regulations
- •Interpret and recommend modifications to companywide policies and practices
- •Interface with outside regulatory agencies
- •Identify, correct, and prevent compliance issues
- •Support the quality system
- •Assist all CN business units in complying with MDD, MDR, and national legislation in EU, Middle East, and Africa
- •Manage relationships with Competent Authorities and Notified Bodies
- •Act as contact for the EC Authorized Representative for Abbott Medical Cardiovascular & Neuromodulation
- •Coordinate with the legal manufacturer on Field Action materials and documents for EMEA
- •Determine plans, methods, timelines, and rollouts for FSCA
- •Maintain and improve Regulatory Compliance activities in EMEA
- •Monitor compliance with company policies and procedures
- •Make decisions on work processes and operational plans to achieve compliance objectives
- •Recruit, coach, and develop organizational talent
- •Support inspections by outside Regulatory Agencies and internal audits
- •Lead quality support activities related to product and process performance issues through the CAPA system
Tools & Technologien
MS Office (Word, Excel, Outlook)
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Betriebliche Altersvorsorge
- •Attractive Abbott Pension Plan
Firmenfahrrad
- •Company bike
Attraktive Vergütung
- •Employee stock purchase program
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Abbott Medical GmbH 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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