The Compliance Specialist (Level 2) - QMS & OQLF Focus plays a critical role in ensuring the organization adheres to ISO 13485 (Quality Management System) and OQLF (Office québécois de la langue française) regulations. This role is designed as a key contributor within the compliance team, with a focus on leading internal compliance efforts in these areas while also supporting broader compliance activities related to HIPAA, PIPEDA, PIPA , and Law 25. Positioned as a precursor to a Senior Compliance Specialist role, this position is ideal for a candidate looking to advance their career in compliance. The Compliance Specialist (Level 2) reports directly to the VP - IT, Integration & Security.
What you'll do:
ISO 13485 (QMS) Audit Leadership: Lead internal efforts for ISO 13485 audits, preparing documentation, coordinating with internal teams, and liaising with external auditors.
QMS Management: Oversee the development, implementation, and improvement of the Quality Management System in accordance with ISO 13485 standards.
OQLF Compliance: Ensure compliance with OQLF regulations, managing relevant documentation, and ensuring timely reporting and adherence to language laws.
Support for broader compliance areas: Assist in maintaining compliance with other regulatory frameworks, such as ISO 27001, HIPAA, PIPEDA/PIPA , and Law 25.
Training and Awareness: Develop and deliver training programs focused on ISO 13485 and OQLF, and support broader compliance training initiatives.
Continuous Improvement: Continuously monitor and improve compliance processes, particularly in QMS and OQLF areas, identifying areas for enhancement.
Documentation and Reporting: Maintain accurate and up-to-date compliance documentation and prepare reports for management and external stakeholders
Who you are:
Bachelor’s degree in Business Administration, Healthcare Administration or a related field.
3-5 years of experience in compliance, with specific experience in ISO 13485 and familiarity with OQLF requirements.
Knowledge and experience with compliance frameworks such as ISO 13485, HIPAA, PIPEDA, PIPA , and Law 25 (considered an asset)
Strong organizational and project management skills, particularly in leading audits and managing compliance initiatives.
Bilingual (French and English) with strong communication skills, both written and verbal.
Ability to work independently, prioritize tasks, and adapt to a dynamic regulatory environment.
Key Qualities
Customer Service Orientation: Focus on providing high-quality service and compliance solutions to internal and external stakeholders.
Communication Skills: Ability to clearly communicate complex compliance issues to non-technical stakeholders, with a particular focus on ISO 13485 and OQLF requirements.
Attention to Detail: High level of accuracy in managing compliance documentation and processes, especially in regulated areas like QMS.
Proactive Approach: Anticipate potential compliance issues, particularly those related to QMS and OQLF, and take preventive actions.
Ethical Standards: Maintain the highest standards of confidentiality, privacy, and data protection in all compliance activities.
Continuous Learning: Stay current with the latest regulatory changes and best practices, with a focus on ISO 13485 and OQLF compliance.
Performance Expectations
Timely Project Delivery: Meet deadlines for compliance projects, audits, and training initiatives, with a particular focus on QMS and OQLF-related activities.
Quality of Work: Maintain high standards in all compliance activities, ensuring alignment with organizational goals and regulatory requirements.
What’s in it for you?
By joining MEDFAR, you will be part of a purpose-driven organization whose product is disrupting and digitizing health care, making doctors’ and healthcare workers’ lives easier, while enabling better patient health outcomes. Becoming a MEDFARian also means having the opportunity to be part of an innovative community and working in a dynamic environment where your work will have a meaningful and tangible effect not only on your team and the business but most importantly on the healthcare industry.
You decide where you do your best work (at home or the office)
Flexible hours (work-life balance)
Performance-based bonus for all employees.
Generous group insurance coverage as of day 1 of employment
Break paid between Christmas and New Years
Annual $ 1,500 training allowance for your professional development
An entrepreneurial culture of transparency, collaboration, and innovation
Our Recruitment Process at MEDFAR:
Virtual Screen with HR >> Hiring Manager Interview >> Panel Interview >> Offer
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