Senior Manager, Regulatory Compliance(m/w/x)

Vollzeit

Senior

Keine Angabe

Eschborn

Nejo KI-Zusammenfassung

In this role, you will oversee regulatory compliance for the Cardiovascular and Neuromodulation business units in EMEA, ensuring adherence to internal and external regulations. You will manage relationships with regulatory authorities and lead quality support initiatives.

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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
•Establish and maintain the quality system with oversight
•Interpret and recommend modifications to companywide policies and practices
•Interface with outside regulatory agencies
•Identify, correct, and prevent compliance issues
•Support the quality system across all business units
•Ensure compliance with MDD, MDR, and national legislation in EU, Middle East, and Africa
•Manage relationships with Competent Authorities and Notified Bodies
•Serve as contact for the EC Authorized Representative for Abbott Medical Cardiovascular & Neuromodulation
•Coordinate Field Action related 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

Tools & Technologien

MS Office

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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