Healthcare Compliance Project Coordinator

vor 1 Monat

Plattling, Bayern, Deutschland CSA Group Vollzeit

Employment Status:

Regular

Work Hours:

Full time

We need your expertise to build a world-class team
CSA Group is committed to a vision of making the world a better, safer, and more sustainable place. This ideal has been at the core of our mission since 1919, when we developed our first engineering standard for railway bridges. Nearly a century later, CSA Group has established over 3,500 standards, codes, and related products.

Headquartered in Canada, CSA Group operates globally with more than 30 laboratories and offices across Europe, Asia, and North America. We provide testing, inspection, and certification services for a wide range of products—from household items to advanced technologies—to ensure they meet stringent safety, performance, and environmental impact requirements.

Our employees take pride in knowing their work positively impacts people's lives. We seek individuals like you to further our mission.

Job Summary:

CSA Group Europe is seeking a Healthcare Regulatory Project Planner (f/m/d) to enhance our Healthcare Regulatory Services Team across Europe.
The Regulatory Project Planner will operate within the Healthcare Regulatory Management System Certification domain, serving as the primary individual responsible for the technical planning of assessments based on client application insights.

Your responsibilities include:

Conducting technical evaluations of applications and providing clients with feedback on the completeness and plausibility of their submissions Ensuring assessments are planned and scheduled within the appropriate timeframes, considering all relevant technical aspects of the certification programs Confirming that all necessary resources for compliant assessment performance are available Reviewing client applications in light of regulatory requirements pertinent to the certification programs Acting as an interface to sales teams as needed, providing technical information on available programs and customer-specific details to promote laboratory services Assisting the Head of Medical Regulatory Services in establishing and implementing operational procedures for application review and project planning, as well as demonstrating to relevant authorities that effective procedures and protocols are in place Participating in the planning, preparation, and presentation of content for auditor experience exchange and technical training events Collaborating with clients during the planning phase to ensure compliance with national/international standards while maintaining confidentiality

What we expect:

A Bachelor's degree in technical, medical, or scientific fields or equivalent professional knowledge Over 4 years of relevant experience in management system certification within the medical device sector Familiarity with global medical device conformity assessment programs (e.g., MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA) Understanding of relevant regulations, directives, and guidelines for the certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), relevant MDCGs, and the role of the Notified Body Strong interpersonal skills; self-motivated; excellent organizational abilities Capability to manage multiple clients and adapt to changing schedules and deadlines with supervision Exceptional communication skills (both verbal and written) Strong conflict resolution abilities to handle challenging situations Qualification as a management system auditor in the healthcare sector is advantageous Technical expertise in two or more primary technical areas (IAF MD9) is a plus Proficiency in German and English, both written and spoken. Knowledge of additional European languages is beneficial.

What we offer:

Flat hierarchies in a professional and multicultural corporate environment Opportunities for remote work and flexible working hours Engaging tasks, exciting projects, and the chance to contribute your ideas Fitness and health programs to maintain a balanced work routine Bicycle leasing options Company pension plan Additional corporate benefits

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