Mona Lisa is one of the world’s leading manufacturers of copper intrauterine devices.
The current portfolio includes a variety 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 Jr. 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.
• 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 1 year 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
Job Type: Full-time
Work Location: Hybrid remote in 3540 Herk-de-Stad