Abbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Vollzeitnur vor OrtSenior
Eschborn
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ABAbbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Eschborn
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing compliance function and quality system development for Cardiovascular & Neuromodulation in EMEA at a healthcare solutions provider. 7+ years in regulated industry with QMS/audit experience and leadership track record required. Company bike and employee stock purchase program.
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
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
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 function and quality system development for Cardiovascular & Neuromodulation in EMEA at a healthcare solutions provider. 7+ years in regulated industry with QMS/audit experience and leadership track record required. Company bike and employee stock purchase program.
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
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
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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Senior Manager Regulatory & Compliance(m/w/x)
Vollzeitnur vor OrtSeniorDüsseldorf, München, Frankfurt am Main, Hamburg, Stuttgart - Citrus Global
IT Systems Compliance Manager – Engineering(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Mainab 90.000 - 100.000 / Jahr - Fresenius Kabi Deutschland GmbH
Regulatory Compliance Specialist Enteral Nutrition(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBad Homburg vor der Höhe