Executive Director General Manager EMEA f/m/d Post Market Surveillance Complaint Management, HAMBURG

Executive Director / General Manager EMEA (f/m/d) Post Market Surveillance, Complaint Management

Olympus Winter & Ibe GmbH (OWI) | Medical Systems

As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Your responsibilities

• Responsible for Reporting on global Manufacturing Incident Reports (MIR). Including management and execution of global MIR procedures, local work instructions, practices and compliance of complaint and reporting performance, working in a global cross functional team
• Responsible for cross functional teams (Medical Safety, Field Safety, Manufacturing, and R&D) that evaluate product risk and potential safety issues. The teams will assess deaths, serious injuries, and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable
• Hire, develop and organize a department of engineers, technicians, medical professionals, including managers, such that the team meets all requirements in an efficient, process, results oriented manner
• Work closely with Medical Safety Office (MSO) to ensure consistency in medical evaluations is performance and documented in HHEs.
• Responsible for working in partnership with Design Quality Assurance (Design QA) in resolving customer issues and developing continuous process improvement initiatives.
• Work with Olympus management and Design QA to ensure field performance and safety issues are properly addressed for new product requirements and/or risk management files
• Develop and implement programs to review literature and internet for potential complaints and AE/MIRs
• Serves as a Core leadership team member reporting directly to the VP, Global Complaints Management

Must haves

• Minimum of 10 years management level experience in a global drug/ medical device manufacturer
• Strong concentration in complaint handling and MIR reporting, including experience with USA and EU Quality System Regulations (QSR)
• Experience with a minimum leadership scope of 60 + people


Other important qualifications

• Bachelor of Science in medical, engineering, or scientific discipline
• Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
• Proficient understanding of medical device regulations both domestic and international with specific expertise in; Complaint Handling, Adverse Event Reporting, Field Actions/Recalls, Regulator Inspections, product performance trending, risk management, and Corrective and Preventive Actions (CAPA)
• Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.
• Willingness to work in a global organisation with national and international travel

The Interview will be competence based and the following competencies will be assessed:

· Build for the Future
· Deliver Results
· Lead People
· Lead Self
· Model and champion Our Core Values

• A comprehensive company pension scheme
• Employee restaurant with live cooking and healthy food (subsidized) as well as fully equipped office kitchens
• Christmas Bonus & Holiday Pay
• Employee Assistance Program & famPLUS
• Corporate Health Care
• Subsidized public transport ticket
• Flexible Working Time
• Various company sports groups
• Bike leasing (JobRad)
• Capital-forming Payments
• 30 days of holiday
• Up to 60 % mobile working possible

About Olympus Medical Systems

The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

About Olympus Medical Systems

The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

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