Compliance and Quality Assurance Leader

1 week ago


Singapore RESPIREE PTE. LTD. Full time

We are looking for a Compliance and Quality Assurance Leader to join our team at RESPIREE PTE. LTD. As a key member of our organization, you will play a crucial role in ensuring that our products meet the highest standards of quality and regulatory compliance.

Responsibilities
  1. Develop and implement quality management systems (QMS) that align with international standards (ISO 13485).
  2. Collaborate with cross-functional teams to ensure effective implementation of regulatory requirements and strategies.
  3. Maintain accurate records of regulatory submissions, post-market surveillance, and audits.
  4. Provide training to employees on regulatory and quality requirements.
Requirements
  • Bachelor's degree in Life Sciences, Biomedical Engineering, or a related field.
  • At least 5 years of professional experience in regulatory affairs and/or quality affairs in the medical device industry.
  • Strong attention to details with the ability to manage multiple priorities and deadlines.
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Office.

The successful candidate will possess excellent problem-solving skills, be able to work independently, and have a strong understanding of regulatory and quality standards. If you are a motivated and detail-oriented individual with a passion for quality assurance, please apply for this exciting opportunity.



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