Abbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Full-timeOn-siteSenior
Eschborn
New Job?Nejo!
The AI Job Search Engine
ABAbbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Eschborn
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
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.
Not a perfect match?
- EY
Senior Manager Regulatory & Compliance(m/w/x)
Full-timeOn-siteSeniorDüsseldorf, München, Frankfurt am Main, Hamburg, Stuttgart - Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Citrus Global
IT Systems Compliance Manager – Engineering(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Mainfrom 90,000 - 100,000 / year - STADA Arzneimittel AG
Senior Manager Sanctions & AML(m/w/x)
Full-time/Part-timeOn-siteSeniorBad Vilbel
ABAbbott Medical GmbH
Senior Manager, Regulatory Compliance(m/w/x)
Eschborn
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
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?
- Abbott Medical GmbH
Senior Manager Regulatory Compliance(m/w/x)
Full-timeOn-siteSeniorEschborn - EY
Senior Manager Regulatory & Compliance(m/w/x)
Full-timeOn-siteSeniorDüsseldorf, München, Frankfurt am Main, Hamburg, Stuttgart - Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Citrus Global
IT Systems Compliance Manager – Engineering(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Mainfrom 90,000 - 100,000 / year - STADA Arzneimittel AG
Senior Manager Sanctions & AML(m/w/x)
Full-time/Part-timeOn-siteSeniorBad Vilbel