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Società ATS:  Comecer
ID richiesta:  3716

Joure, FR, NL, 8501 XC

Data:  11-lug-2021

Regulatory Affair

Job Details

Job Title: Person Responsible for Regulatory Compliance
Location: Netherlands, Joure
Reporting to: QA Manager

Job Purpose

Comecer Netherlands BV in Joure develops, produces, and sells innovative (medical) devices and software for Nuclear Medicine departments in hospitals and industry. Comecer Netherlands BV is part of Comecer group and is an ATS Automation company. Our products are sold worldwide.
We are searching for a Person Responsible for Regulatory Compliance (PRRC) who will be responsible for technical compliance with legislation, regulation and directives that are applicable in our global market.
Providing input into the Quality and Product Development team to ensures that compliance to all regulatory requirements under the letter of the Medical Device Regulations (MDR) and other standards is demonstrated.

Duties and Responsibility

Qualifications and / or Experience Required

  • HBO/University in Engineering, Quality/Regulatory Affairs, or a related equivalent discipline.
  • Experienced regarding applicable quality system regulations and standards such as 21CFR820 and ISO 13485.
  • Knowledge of, or strong affinity with MDR, LVD, EMC, MD and related IEC and ISO standards.
  • Minimum of 4 years of experience within a medical device company or highly regulated industry preferable in a QA or RA role.
  • Strong analytical skills and data-driven thinking.
  • Experience in product development and life cycle management (product maintenance). Referable both with software development and/or hardware/systems development.


Desired Skills and Experience

  • Ability to communicate across different levels of the organization, with customers and notified bodies.
  • Flexible, enthusiast and proactive.
  • Hands-on mentality to get the job done.
  • Excellent time management and organizational skills.
  • Excellent attention to detail in oral & written communication is a must, with a proven technical protocol & report writing background.
  • Experience in medical devices is considered a plus.
  • Accurate and social
  • Languages: Dutch and English
  • Driving license B

What We Offer

  • A challenging, varied, and responsible job in a nice atmosphere with highly motivated colleagues.
  • A competitive salary and growth opportunities.

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