Employment opportunity

ABIOMED Europe GmbH, headquartered in Aachen, Germany is looking to fill the following positions:

Regulatory Affairs Coordinator m/f

Tasks

• Prepare and update declarations of conformity for the ABIOMED products
• Maintain an overview of applicable standards, directives (Directive 93/42/EEC), Medical Product Law (MPG)
• Control and coordinate testing methods and procedures; monitor and validate microbiological examination procedures
• Create and manage the Design History Files and the Device Master Records for the products
• Maintain a documentary feedback system for early warning (monitoring system)
• Handle complaints according to laws, directives, and standard operating procedures

Profile

• Medical-technical training / University Degree as Graduate Engineer or Biologist with technical understanding
• At least 2 years in relevant regulatory function in the medical product industry
• Familiarity with medical technical and legal standards, research and knowledge transfer, documentation and presentation
• PC user knowledge

Clinical Research Assistant m/f

Tasks

• Assist in generation of clinical investigation protocols (CIP), and ensure conformity of CIPs with applicable laws and guidelines (MPG, ISO 14155, GCP)
• Assist in trial site selection and training
• Generate CRF templates (Case Record Forms)
• Perform query management (evaluate incoming CRFs, generate and distribute queries, follow-up on queries)
• Assist in generation and validation of data bases; assist in data analyses and reporting
• Perform literature search and analyses

Profile

• Medical-technical training / University degree as natural scientist, nurse with advanced knowledge in clinical trials
• Experience in management of clinical trials with medical products
• Familiarity with data base handling (Access)
• Basic knowledge in cardiology, presentation skills, basic medical writing skills

Financial Planner & Analyst („FP&A“) m/f

Objectives:

• Preparation of the Monthly Reporting Package and Analytical Review to achieve the targets of the Monthly Closing Process
• SAP Financial Reporting in USGAAP and in HGB, Business Planning and Forecasting
• Business Partner of the Functional Heads in Germany and the Corporate Functional Heads in the US
• Continuous Improvement of the Planning – and the Control Instruments in SAP, incl. Sales Controlling
• Interface between Finance, Controlling, Customer Service, External Auditors, Tax Advisors and Corporate in the US
• Support Audit- and SOX Processes related to the Reporting, Analytical Review and Cost of Sales Method (“Umsatzkostenverfahren”)
• As SAP Key User participate in committees organized on Corporate Level

 Assignments/Tasks:

Responsible for the analysis of financial data, defining measures for improvements and follow up of the execution.

The ERP system generates the basic information. The FP&A has to interpret these data to identify areas of concern about performance which should be highlighted, followed by the definition and the execution of measures for improvement. Based on the agreed commitments, perform a regular review to do the necessary corrections. Partners with the  Management in Germany and in the US and the Director Finance Europe to improve the financial performance.

Workload is quite heavy and the personal commitment to goals & objectives is essential. Must work as a team player, accepted cross functional. As a service and support provider supporting the achievement of critical deadlines. This makes it necessary to be merciless in the achievement of committed targets.

Responsible for:  

• Support the Functional - and Corporate Functional Heads
• Speed up financial reporting to provide simplified financial reports for business decisions
• Define and execute improvement measures in the area of Finance and Controlling
• Permanent development of the MIS including Sales Reporting
• Partner in the overall tax optimization – and SOX testing processes

Cooperation with:  

Internally frequent contact with the Functional Heads in Germany and in the US, Customer Service, Finance, Controlling and Corporate Finance/Accounting.

Close cooperation with the Management and the Director Finance Europe.

Contact with internal and outside auditors and advisors.

Requirements:

Educational Skills: Graduate in economics, especially Cost Accounting/Controlling; Requires practical experience (working knowledge), minimum 5 years, as Controller/FP&A.

Working Experience: Ability to plan and organise his responsibilities to meet deadlines. Good analytical skills with high degree to accuracy. Must be able to identify problems, define measures and to present possible solutions to Management. Effectively communicate with the Functional Heads, Customer Service, Finance, Controlling and Corporate Finance/Accounting in German and in English.

Special Requirements: SAP R/3 skills, as well as MS Office (Excel, Access etc.), English

Production Controlling m/f

Objectives:

• Review and Improve all production processes towards Process Reengineering and Benchmark
• Monitor the impact of cost saving measures & increases in efficiency on current and future returns
• Update the standard costs and perform the product calculations, product pricing, preliminary costing, concurrent costing and ex-post costing
• Continuous Improvement of the operating expenses control and implementation of an OpEx Report with integrated feedback from the Functional Heads in Germany and the US
• Interface between Finance, Controlling, Production, R&D, Quality, Supply Chain, Material Management and Corporate in the US
• Coordinate the budget- and forecast preparation and improve the production controlling
• As SAP Key User participate in committees organized on Corporate Level

Assignments/Tasks:

Responsible for the analysis of production data and the reporting of production related key figures, e.g. Overall Equipment Efficiency, Scrap, ROI, defining measures for improvements and follow up of the execution.

The ERP system generates the basic information. The Production Controller has to interpret these data to identify areas of concern about performance which should be highlighted, followed by the definition and the execution of measures for improvement. Based on the agreed commitments, perform a regular review to do the necessary corrections. Partners with the  Management in Germany and in the US and the Director Finance Europe to improve the overall production performance.

Workload is quite heavy and the personal commitment to goals & objectives is essential. Must work as a team player, accepted cross functional. As a business partner supporting the achievement of critical deadlines. This makes it necessary to be merciless in the achievement of committed targets.

Responsible for:  

• Introduce a reliable tool set, accepted and automated
• Define and execute improvement measures in production and in all production related areas
• Permanent development of the MIS reconciled with the financial accounting data
• Partner in the overall production optimization in Europe and in the US
• Investment Control and Return on Investment calculations
• Permanent analysis and follow up on productivity, capacity and inefficiencies, scrap etc.

Cooperation with:

Internally frequent contact with the Director Production, the Director Supply Chain Management, the Director Quality, the R&D Program Manager, Finance and Controlling in Germany and the US

Close cooperation with the Management and the Director Finance Europe.

Contact with internal and outside auditors.

Requirements:

Educational Skills: Graduate in economics, especially Cost Accounting/Production Controlling; Requires practical experience (working knowledge), minimum 5 years, especially in a production company as Production Controller/Cost Accountant.

Working Experience: Ability to plan and to organise his responsibilities to meet deadlines. Good analytical skills with high degree to accuracy. Must be able to identify problems, define measures and to present possible solutions to Management. Effectively communicate with the Production, Supply Chain, Material Management, Quality, Finance, Controlling and Corporate  in German and in English.

Special Requirements: SAP R/3 skills, in particular PP, as well as MS Office (Excel, Access etc.), English

For further information or job opportunities please see additional jobs listed in German:

SAP Administrator f/m

Manufacturing Engineer f/m

Senior Compliance Manager f/m

Contact Address:
Abiomed Europe GmbH
Human Resources
Neuenhofer Weg 3
D-52074 Aachen, Germany
Email :eu_personal@abiomed.com

What we require of our employees:

As a high-tech manufacturer of extremely demanding products where mistakes are not allowed in production or use of the products, Abiomed Europe is compelled to place very tough demands on all of its employees. We expect:

• Outstanding specialized expertise
• Flawless product quality and flawless work performance from each individual team member
• Care and a sense of individual responsibility in pursuing interdivisional cooperative efforts
• Problem solving thought and action
• Identification with the team, initiative, reliability and commitment

What can you expect as an Abiomed Europe employee?

• Open communication and comprehensive information
• Creative freedom within the framework of assigned responsibilities and stated goals
• Promotion of your professional and personal development
• Sharing in the success and increasing value of the company

We work and live together in full awareness of the fact that expert qualifications and the personal development of company employees, at all levels of responsibility, are our most valuable asset and most important success factor.

Corporate culture and working atmosphere

The specialized expertise and personality profiles of our employees at all levels of responsibility are our most valuable asset, and are the most important success factor for continuing development of the company.

The working atmosphere is characterized to a great extent by three aspects:

• A corporate culture which is based upon legitimacy and trust, as well as practical and human esteem.
• A participative, encouraging and demanding management style, which is defined in terms of a target oriented approach, personal responsibility, and commitment to entrepreneurial thought and action – the fact that comprehensive information, open lines of communication and interdivisional cooperation are absolutely essential goes without saying.

A team of highly qualified experts who identify with the company's mission and objectives, as well as with their own responsibility for the company – no "yes men", but rather problem solvers, even when faced with contentious disputes, in short: people who give their best every day in terms of competence and commitment, and who mutually celebrate their successes and bear responsibility for setbacks.