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Regulatory Affairs Specialist

7 months ago

Montréal, Canada vitaltracer Full time

Work Term: Permanent
- Work Language: English
- Hours: 42 to 44 hours per week
- Education: Master's degree
- Experience: 5 years or more
**Tasks**:

- Analyze and provide advice on the managerial methods and organization of an establishment
- Conduct quality audits
- Develop quality management and quality assurance standards
- Conduct research to determine efficiency and effectiveness of managerial policies and programs
- Propose improvements to methods, systems and procedures
- Coaching
- Plan and control budget and expenditures
- Set up medical laboratory equipment
**Supervision**:

- 1 to 2 people
**Regulatory investigation**:

- Regulatory affairs
**Computer and technology knowledge**:

- Microsoft Visio
- MS Word
- MS Excel
- MS PowerPoint
- MS Outlook
- MS Office
**Industrial processes and biological studies**:

- Product development
**Type of inspection and investigation**:

- Medical devices
**Area of work experience**:

- Medical instruments and devices
- Research and development
**Medical specialization**:

- Biomedical engineering
**Area of specialization**:

- Process improvement
- Risk management
- Organizational analysis
- Operations management
- Operational methods research
- Program evaluation and review
- Ethical oversight and accountability framework assessment
- Project management
- Internal audit
- Cybersecurity
- Facility management
- User experience design
**Work conditions and physical capabilities**:

- Work under pressure
- Tight deadlines
- Overtime required
**Personal suitability**:

- Efficient interpersonal skills
- Excellent oral communication
- Excellent written communication
- Flexibility
- Team player
- Time management
**Screening questions**:

- Are you currently legally able to work in Canada?
- Are you willing to relocate for this position?
- Do you currently reside in proximity to the advertised location?
- Do you have previous experience in this field of employment?
- Do you have the above-indicated required certifications?
- Do you have the necessary equipment for remote work (i.e. internet, home office, etc.)?
- What is the highest level of study you have completed?
- What is your current field of study?
- What is your current level of study?