Complaints Analyst I

At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.
Are you looking for an inspiring career? You just found it.
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope - just to name a few.
We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.
We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.
We have an opening for a Complaints Analyst I. This position supports and provides assistance in the evaluation of Product Complaints for Medical Device Reporting (MDR) and Vigilance (MDV) reports. This position is responsible for reporting of complaints and processing of trend analysis in accordance with department procedures and applicable regulatory requirements. Work closely with members of Sales and Servicing Unit (SSU), Engineering, Marketing, Medical, Regulatory, and Quality departments. May interact with external customers, hospital staff, and/or other external personnel as required.
Job Functions:

• Work in a team environment with members of the SSU and QA-Product Surveillance groups on receiving complaints in the complaint system.
• Work in a team environment with members of the Engineering and Medical teams on completion of Decision Tree (DT) and completion / submission of Initial MDRs.
• Work independently and with different parts of the organization/departments to perform Good Faith Effort (GFE) to obtain required / additional event information and request sample return.
• Ensure complaints are handled in compliance with applicable regulations and regulatory standards.
• Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) and reportability requirements for various countries.

Required Knowledge, Skills and Abilities:

• High School degree or equivalent required. A Bachelor's degree in a Science or related technical field is preferred.
• A minimum of 2-3 years in medical device or other regulated environment is preferred.
• Critical thinking skills - the ability to analyze information objectively and make a reasoned judgment.
• Analytical skills - theability to carefully examine something, whether it is a problem, a set of data and then understand what it means or what it represents.
• Knowledge of working with quality systems per 21 CFR 820, 21 CFR 803, ISO 13485 is preferred.
• Knowledge in record keeping, computer software, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred.
• Ability to communicate clearly and concisely (written and oral), including technical writing skills.
• Proficiency with Microsoft Office Word, Excel, Visio, Power Point, or equivalent software applications is required.

About us
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise 'Passion for Life' close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.