Abbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Full-timeOn-siteSenior
Eschborn
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ABAbbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Eschborn
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office (Word, Excel, Outlook)
Benefits
Retirement Plans
- Attractive Abbott Pension Plan
Company Bike
- Company bike
Competitive Pay
- Employee stock purchase program
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Abbott Medical GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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ABAbbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Eschborn
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office (Word, Excel, Outlook)
Benefits
Retirement Plans
- Attractive Abbott Pension Plan
Company Bike
- Company bike
Competitive Pay
- Employee stock purchase program
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Abbott Medical GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Abbott Medical GmbH
Industry
Healthcare
Description
Das Unternehmen ist ein weltweit führendes Unternehmen im Gesundheitswesen, das bahnbrechende wissenschaftliche Erkenntnisse nutzt und Lösungen zur Verbesserung der Gesundheit der Menschen entwickelt.
Not a perfect match?
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