Senior Quality Assurance/Regulatory Affairs Specialist

2 weeks ago

Toronto, Ontario, Canada Mimosa Diagnostics Full time

About Mimosa Diagnostics:

Mimosa Diagnostics is a leading company in the field of skin health and wound care. Our mission is to provide innovative solutions that empower clinicians to deliver exceptional patient care.

Job Summary:

We are seeking an experienced Senior Quality Assurance/Regulatory Affairs Specialist to join our team. In this critical role, you will be responsible for ensuring the quality and regulatory compliance of our products. This includes developing and implementing quality assurance strategies, conducting internal audits, and preparing regulatory documents.

Key Responsibilities:

  1. Develop and implement quality assurance strategies and regulatory compliance programs to ensure adherence to quality standards and regulatory requirements.
  2. Conduct internal audits, inspections, and periodic quality monitoring to ensure compliance with quality standards and regulatory requirements.
  3. Prepare and submit regulatory documents to relevant agencies, including Health Canada and the United States FDA.
  4. Collaborate with cross-functional teams to address quality and regulatory issues.
  5. Monitor and analyze changes in regulations and industry standards to ensure ongoing compliance.
  6. Provide training and support to staff on quality assurance and regulatory affairs best practices.
  7. Review and approve validation protocols, change controls, and deviation reports.
  8. Lead investigations related to product quality issues and implement corrective actions.
  9. Maintain and update quality documentation, including SOPs, work instructions, and quality manuals.
  10. Serve as the main point of contact for regulatory agencies, including Health Canada and the United States FDA, and manage communications effectively.

Requirements:

  1. Bachelor's degree in Science, Life Sciences, Engineering, or a related field; advanced degree preferred.
  2. Minimum of 3 years of experience in quality assurance and regulatory affairs, preferably in the medical device industry.
  3. In-depth knowledge of regulatory requirements, including FDA, ISO, and MDSAP.
  4. Experience with preparation and approval of regulatory submissions for medical devices to a major regulatory authority.
  5. Proven experience in conducting audits and inspections.
  6. Strong analytical and problem-solving skills.
  7. Excellent communication and interpersonal skills.
  8. Ability to work independently and collaboratively in a fast-paced environment.
  9. Manage and control documents in an electronic quality management system.

What We Offer:

Mimosa Diagnostics offers a comprehensive benefits program, employee stock option plan, discretionary time off, and a hybrid work environment. We are committed to cultivating a diverse and inclusive workplace that reflects different abilities, backgrounds, beliefs, experiences, identities, and perspectives.

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