Healthcare Regulatory Project Planner

Employment Status:

Regular

Time Type:

Full 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:

CSA Group Europe has an opportunity for a Healthcare Regulatory Project Planner (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
The Regulatory Project Planner will perform in the Healthcare Regulatory Field of Management System Certification as the person responsible for technical planning of assessments based on the understanding of information from clients’ applications.

These are your duties:

• responsible for technical evaluation of applications including feedback to the client on completeness and plausibility of applications

• to ensure that assessments are planned and scheduled within the appropriate timeframe under consideration of all relevant technical aspects of the underlying certification programs

• to ensure that all required resources for compliant performance of an assessment are available

• to perform the review of clients’ applications under consideration of regulatory requirements of the underlying certification programs

• an interface position to the sales teams where needed and provide technical information on the offered programs as well as customer-specific information to cross-sell laboratory services where applicable

• to support the Head of Medical Regulatory Services in establishing and implementing the operation procedures towards towards application review and project planning as well as in demonstrating to the relevant authorities that appropriate procedures and protocols are in place and effective

• involved in the planning, preparation and demonstration of contents for auditor experience exchange and technical training events

• to liaise with customer in planning stage to ensure requirements of national / international standards are met without compromising confidentiality

What we expect:

• Bachelor degree in technical, medical or scientific university or polytechnic studies or comparable professional knowledge
• 4+ years of relevant experience in management system certification in the field of medical devices
• Knowledge of global medical device conformity assessment programs (e.g., MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA)
• 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
• Strong interpersonal skills; self-starter; good organizational skills.
• Ability to manage multiple clients and changing schedules and deadlines with supervision
• Excellent communication skills (verbal and written)
• Strong conflict resolution skills to be able to handle difficult situations
• Qualification as management system auditor in the healthcare sector is a benefit
• Technical competence in 2 or more main technical areas (IAF MD9) are a benefit
• 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

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 human.resources@csagroup.org if you require accommodation in the interview process.