Abbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Vollzeitnur vor OrtSenior
Eschborn
Neuer Job?Nejo!
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ABAbbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Eschborn
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing compliance for Cardiovascular & Neuromodulation business units in EMEA healthcare, developing quality systems at global healthcare leader. 7+ years in regulated industry with proven leadership track record required. Company bike, employee stock purchase program.
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
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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office (Word, Excel, Outlook)
Benefits
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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ABAbbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Eschborn
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing compliance for Cardiovascular & Neuromodulation business units in EMEA healthcare, developing quality systems at global healthcare leader. 7+ years in regulated industry with proven leadership track record required. Company bike, employee stock purchase program.
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
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
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office (Word, Excel, Outlook)
Benefits
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.
Über das Unternehmen
Abbott Medical GmbH
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein weltweit führendes Unternehmen im Gesundheitswesen, das bahnbrechende wissenschaftliche Erkenntnisse nutzt und Lösungen zur Verbesserung der Gesundheit der Menschen entwickelt.
Noch nicht perfekt?
- Abbott Medical GmbH
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