Regulatory Certification Decision Maker (m/f/d)

CSA Group Healthcare Testing & Certification GmbH; Plattling; On-site; EUR 65,000 - 90,000; Full time

Job summary

CSA Group is seeking a Certification Decision Maker in Germany to evaluate conformity assessment documentation and final review outcomes for healthcare certification or related programmes. The role requires determining whether certification requirements are fulfilled and what action is justified.

CSA Group is an Equal Opportunity Employer committed to diversity, equity, and inclusion, with a global network of labs and offices. Contact [e-mail] for interview accommodations.

Qualifications

• Independent case-specific certification decisions based on documentation.
• Evaluation within applicable programme and authorisation to determine required certification action.

Responsibilities

• Make independent certification decisions on conformity assessment packages.
• Evaluate packages and determine justified certification actions within programme constraints.

Skills

Certification decisions

Conformity assessment

Final Review process

Job description

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:

The Certification Decision Maker role takes independent case-specific certification decisions on the basis of completed conformity assessment documentation and the independent Final Review outcome for the applicable healthcare certification or conformity assessment programme. The Certification Decision Maker evaluates the decision package and determines, within the applicable programme and individual authorisation, whether the requirements for certification are fulfilled and what certification action is justified.

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 [e-mail] if you require accommodation in the interview process.

CSA Group’s Testing, Inspection, and Certification (TIC) services help customers around the world demonstrate compliance, build trust, and bring safe, reliable products to market.

CSA Group’s Testing, Inspection and Certification (TIC) organization supports market access and innovation, addressing the compliance of emerging, complex technologies through expert testing, inspection, and certification services.

CSA Group provides comprehensive testing, inspection, and certification services that help global manufacturers demonstrate compliance with applicable safety, environmental, and performance requirements.

We support our clients’ needs in bringing their products to market with confidence, offering deep technical expertise and industry-leading service delivery across a wide range of current and emerging technologies.

Our knowledgeable and helpful assistance builds trust in products, systems, and innovations used every day around the world.

140+ International Markets

Our global labs provide certification services to help you access over 140 markets worldwide.

Established Credibility

We are a true global leader in testing, inspection, and certification, with the CSA mark appearing on billions of qualified products worldwide.

Faster, Reliable Results

Our turnaround times can help get your product to market with speed and efficiency.