CSA Group
Location
Plattling | Germany
Job description
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At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.
Assessor and Competency Administrator, Regulatory Services (f/m/d)
CSA Group Europe has an opportunity for a Assessor and Competency Administrator, Regulatory Services (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Assessor and Competency Administrator will perform in the Medical Device Regulatory Field of Management System Certification as the primary contact for the on-site auditors, technical and clinical experts as well as product reviewers to safeguard the availability of appropriately qualified and competent assessment teams for CSA Medical Device Regulatory Services customers.
Manage and maintain the documentation and provide oversight of the approval status of the Healthcare Regulatory Services’ assessors in CSA’s pool for the different certification programs and their respective technical scopes in the field of medical devices
Ensure that all approvals and the status of each assessor, certification decision maker and subject matter expert is visible to the project planners at any time to adequately prepare the conduct of the different types of assessments
Support the Healthcare regulatory services team in developing and maintaining appropriate procedures for managing, documenting evaluating the technical competency and approval status of assessors (QMS auditor, subject matter expert, technical file assessor, clinical expert, certification decision maker, clinical reviewer, clinical certification decision maker, project planner and other related technical staff) towards the related requirements from regulatory programs and standard-based certification programs in the field of medical devices and IVD
Support the Healthcare Regulatory Services team in establishing and implementing the operation procedures towards customer relations and exchange of information as well as in demonstrating to the relevant authorities that appropriate procedures and protocols are in place and effective
Identify, select and evaluate internal and external technical and clinical staff
Support the team in the organization and conduct of annual auditor experience exchange meetings to maintain required hours of CPD (Continuous Professional Development)
Drive the permanent extension and growth of CSA’s assessors pool by proactively contacting potential assessor candidates, preparing the freelancer contracts and identifying potential candidates for certification decision makers out of this pool
What we expect:
Bachelor’s degree in business administration, pedagogic, medical or scientific university or polytechnic studies; or Post-secondary education in business administration or pedagogic field with 5+ years of professional experience
3+ years of relevant experience in management system certification, preferably in the field of medical devices
knowledge of the relevant regulations, directives and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and2017/746), relevant MDCGs as well as the role of the Notified Body
multiple years of experience in the field of customer related business processes, B2B experience and focus, experience with international/global customers, data analysis and reporting
Strong interpersonal skills; self-starter; good organizational skills
Ability to manage multiple contacts and deadlines with supervision
Excellent communication skills (verbal and written)
Excellent phone and customer service skills
Empathetic, strong conflict resolution skills to be able to handle difficult situations
Computer proficiency in common office applications as well as CRM application
Ability to establish and maintain positive contacts within all levels of the organization to exchange, explain and interpret information or ideas and follow-up on client
Good command in German and English language skill written and oral. Any other European language beside German and English will be a benefit
What we offer:
Flat hierarchies in a professional and intercultural corporate environment
Opportunity to work from home and flexible working hours
Attractive tasks, exciting projects and the opportunity to contribute your own ideas
Fitness and health program for a relaxed balance to the daily work routine
Lease a Bike
Company pension plan
Other Corporate Benefits
Opportunities for constant training/learning
Permanent employment
CSA Group is one of the largest standards development organizations in North America, conducting research and developing standards for a broad range of technologies and functional areas. CSA Group is also a global provider of testing, inspection and certification services for products in many market sectors, and a leader in safety and environmental certification for Canada and the U.S.
The CSA mark appears on billions of products worldwide. For more information about CSA Group, please visit .
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