Regulatory Affairs Officer

☞ Mona Lisa

Visualizza: 135

Giorno di aggiornamento: 07-11-2025

Località: Herk-de-Stad Limburg

Categoria: Altra

Industria:

Tipo di lavoro: Full-time

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Contenuto del lavoro

Mona Lisa is one of the world’s leading manufacturers of copper intrauterine devices.

The current portfolio includes avariety that reflects Mona Lisa’s mission: offering a hormone-free and individual contraceptive method that satisfies the needs of all women.

Currently we are looking for a Regulatory Affairs Officer to join our growing team. We are seeking a collaborative and enthusiastic individual to join our diverse, ambitious and welcoming team. This is a great opportunity to join a family company with strong values that support our customers and employees.

Responsibilities

  • Interface with customers or healthcare professionals to gather additional details on reported complaints, provide assistance, and ensure appropriate follow-up while maintaining compliance with regulatory guidelines and company policies.
  • Ensure prompt and accurate responses to customers and regulatory agencies regarding complaint-related matters, inquiries and requests for information.
  • Ensure compliance with established timelines for complaint evaluation, investigation, closure, and reporting, maintaining thorough records of adherence to regulatory requirements.
  • Integrate Vigilance and PMS processes within the quality management system, ensuring alignment with ISO standards or relevant quality system regulations.
  • Analyze complaint data to identify trends, recurring issues, or potential risks associated with the product.
  • Perform scheduled internal audits of the company’s quality management system against ISO 13485 requirements. Assess and identify potential risks related to non-compliance with ISO 13485 and work with departments to implement corrective and preventive actions to mitigate identified risks.
  • Document and report instances of non-compliance with ISO 13485 standards. Provide detailed information on non-conformities, their root causes, and proposed corrective actions.

Qualifications

Education:

  • Bachelor’s degree in a relevant scientific or engineering field. A Master’s degree or regulatory affairs certification is a plus.

Working experience:

  • At least 3 years of experience in quality assurance and/or regulatory compliance within the medical device or pharmaceutical industry.

Skills:

  • Knowledge of regulatory requirements and standards such as 21CFR820, ISO13485, EU MDR 2017/745, EU MDD 93/42 and MDSAP.
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving skills.

monalisa.eu

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Scadenza: 22-12-2025

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