Corporate Quality Assurance and Regulatory Affairs Specialist

hace 2 semanas

Barcelona, Barcelona, España Sensofar A tiempo completo

Job Summary

We are seeking a highly skilled Corporate Quality Assurance and Regulatory Affairs Specialist to join our team at Sensofar. As a key member of our quality management team, you will play a critical role in maintaining and improving our quality management system while ensuring compliance with regulatory requirements.

Key Responsibilities

  • Develop and maintain quality management system (QMS) documentation, including policies, procedures, and work instructions, in compliance with applicable regulatory standards (ISO 9001, ISO 13485, FDA).
  • Conduct internal audits to assess compliance with QMS requirements and identify areas for improvement.
  • Coordinate external audits by regulatory agencies and notified bodies and assist in addressing audit findings and implementing corrective actions.
  • Review product documentation, including design control documents, technical files, and labeling, to ensure regulatory compliance.
  • Support new product development by providing regulatory guidance and ensuring adherence to quality requirements.
  • Participate in risk management activities, including hazard analysis, risk assessments, and mitigation strategies.
  • Assist in reviewing and resolving nonconformances, deviations, and complaints, ensuring timely investigation and corrective actions.
  • Stay abreast of regulatory changes and industry best practices to inform continuous improvement initiatives.
  • Prepare and maintain the system's post-sales documentation (Site Acceptance, Installation Qualification, Calibration certificates, etc.).

Requirements

  • A bachelor's degree in a relevant scientific or engineering field (e.g., biology, chemistry, or biomedical engineering).
  • Ideal 2-3 years of experience in a quality management or regulatory affairs role.
  • Understanding of regulatory requirements and quality standards, such as FDA regulations (e.g., 21 CFR Part 820) and ISO 13485.
  • Experience with QMS implementation and maintenance, including document control, training, and audit management.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
  • Detail-oriented with strong analytical and problem-solving abilities.
  • Excellent English verbal and written communication skills.

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