Regulatory Technical Reviewer - Healthcare

Position: Regulatory Technical Reviewer (m/f/d) - Healthcare
Location: Germany

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The Regulatory Technical Reviewer - Healthcare provides high quality certification services which meets the clients’ needs in the most efficient and effective manner possible, while ensuring safe products are available in the public marketplace.  CSA Group has an immediate opportunity for a Healthcare Regulatory Technical Reviewer (f/m/d) to join our Healthcare Regulatory Services Team in Germany and throughout Europe.
These are your duties:
To ensure that assessments conducted have properly examined and addressed the regulatory responsibilities of the manufacturer with respect to product clinical performance including alignment with state-of-the-art expectations and defended risk/benefit for the product.

Independently manages certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines.

Evaluates products against requirements of the national / international standards and precedent decisions
* 5+ years of relevant experience in management system certification in the field of medical devices
* Profound knowledge of the relevant regulations, directives and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and
2017/746), relevant MDCGs as well as the role of the Notified Body
* Profound knowledge of global medical device conformity assessment programs (e.g., MDSAP, TCP, JPAL, HKMDACS, UKCA, FDA)
* Multiple years of experience in the field of evaluation and decision making for medical and/or IV devices under regulatory conformity assessment procedures.
* Qualification as management system auditor in the healthcare sector
* Strong interpersonal skills; self-starter; good decision-making skills and organizational skills.

Bachelor’s degree in technical, medical or scientific university or polytechnic studies or comparable professional knowledge

Ability to manage multiple assessments and changing schedules and deadlines with supervision
* 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

Excellent communication skills (verbal and written) Strong conflict resolution skills to be able to handle difficult situations

Ability to travel as needed and/or with short notice (up to 15% travel)
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