Regulatory Technical Reviewer (m/f/d) - Healthcare

Overview

BUILDING A WORLD CLASS TEAM STARTS WITH YOU 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. CSA Group has a history of developing standards and providing certification services to help ensure safety, performance and environmental responsibility of a wide range of products.

Headquartered in Canada, CSA Group operates globally with more than 30 labs and offices across Europe, Asia and North America. We test, inspect and certify products from everyday household items to leading-edge technology to meet exacting requirements for safety and environmental impact. Our employees take pride in making a difference in people’s lives through the work we do. We’re looking for people like you to help make it happen.

Responsibilities

• 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.
• To formulate, maintain and improve assessment procedures and protocols in line with both CSA Group and external Authority expectations.
• 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.
• To support the Commercial team in the formulation and effort estimation for the clinical assessments of product on an as needed basis.
• Delivers assigned projects within agreed timescales.
• Reviews test data and reports.
• Participates in assessments.

Qualifications

• Bachelor’s degree in technical, medical or scientific university or polytechnic studies or comparable professional knowledge.
• 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.
• Technically competent to evaluate all products, including new and unique products, with assistance of other technical staff as necessary.
• Ability to manage multiple assessments and changing schedules and deadlines with supervision.
• Demonstrates technical competence to review the work of others per divisional quality documents.
• Demonstrates technical competence in two or more technical scopes.
• Excellent communication skills (verbal and written).
• Strong conflict resolution skills to handle difficult situations.
• Good command in German and English language skill written and oral. Any other European language beside German and English will be a benefit.
• Ability to travel as needed and/or with short notice (up to 15% travel).

Benefits

• 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.

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