Abbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Vollzeit
Senior
Keine Angabe
Eschborn
AB
Abbott Medical GmbH15 Tage
Senior Manager Regulatory Compliance(m/w/x)
Vollzeit
Senior
Keine Angabe
65760 Eschborn, Helfmann - Park 7
Nejo KI-Zusammenfassung
In this role, you will oversee compliance for the Cardiovascular & Neuromodulation business units across EMEA, ensuring adherence to regulations and quality standards. Your day-to-day responsibilities will include managing relationships with regulatory bodies, supporting inspections, and leading efforts to resolve compliance issues.
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Anforderungen
- •University degree in sciences or related discipline
- •7+ years of related work experience in a regulated industry, including QMS experience and/or experience with regulatory audits and certification management
- •Proven track record in a leadership role with direct reports
- •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 in a geographically diverse, matrixed organization
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
7 Jahre
Deine Aufgaben
- •Manage the compliance function for Cardiovascular & Neuromodulation business units in EMEA
- •Ensure development and implementation of processes and staffing to maintain the quality system
- •Participate in establishing 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
- •Support all business units to comply 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
- •Ensure Field Action materials and documents are suitable for EMEA
- •Determine plan method, timeline, roll out, and reconciliation of FSCA
- •Manage and improve Regulatory Compliance activities in EMEA
- •Monitor compliance with company policies and procedures
- •Make decisions regarding work processes and operational plans to achieve compliance objectives
- •Recruit, coach, and develop organizational talent
- •Support inspections by outside Regulatory Agencies and internal audits, including required responses
- •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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