Assessor and Competency Administrator, Regulatory

Employment Status:
Regular

Time Type:
Part time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

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.

Job Summary:
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.

These are your duties:
- 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- 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)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-
- 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 an Equal Opportunity Employer and is committed to diversity, equity, and inclusion. We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws. We are an organization where opportunities are based on skills and abilities, and differences are respected and valued. Please contact us at _
- if you require accommodation in the interview process._