Careers

Quality Systems / Regulatory Affairs Engineer

March 22, 2024

We are a Den Haag-based medical device startup looking to revolutionize the cataract surgery and ophthalmology industry. We are currently looking to strengthen our quality and regulatory expertise, and we are looking for a Quality Systems / Regulatory Affairs Engineer. In this dynamic position, you will work closely with the QA / RA Manager and collaborate with a motivated team, actively contributing to the development, quality assurance, and certification of a range of medical solutions.

Responsibilities

  • Support the QA/RA Manager to meet quality objectives.  
  • Ensure all Quality Documents meet document control requirements before processing documents in the Quality Management System.  
  • Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.  
  • Guide the team through the Quality Systems and Regulatory Affairs process meticulously, from devising the quality plan to ensuring flawless execution.  
  • Maintain strict adherence to the Quality Management System (QMS).
  • Conduct thorough document reviews and skillfully manage audits.
  • Scrutinize submission documentation meticulously to uphold compliance with regulations.
  • Preparing and Acquiring correct Management and QA/RA approvals where needed.  
  • Work closely with the QA/RA Manager to support the timely implementation of harmonized standards and procedures by executing associated GAP assessments against QMS procedures.

Your Profile

  • HBO in Engineering, Science or Technology related field.
  • Possess a minimum of 2 years of regulatory affairs experience in the medical device industry.
  • Demonstrate proficiency in relevant ISO standards (e.g., ISO13485 and ISO 14971).
  • Experience in preparing and submitting technical documentation to NB as per EU MDR 2017/745.
  • Excellent organizational and communication (verbal and written) skills.
  • Fluent in English.
  • Motivated problem solver with a positive attitude and ability to handle a range of information.
  • Have a passion for quality and an eye for detail.

What’s Offered

  • Competitive, market-based salary with excellent secondary benefits, including a comprehensive pension plan, travel and home working allowance.
  • Hybrid working model with a minimum of 3 days onsite.
  • Fun and collaborative work environment.
  • Free drinks & snacks always available.

Interested?

Send your CV to: jobs@cassini-technologies.com or reach out for additional information.