Quality Assurance and Regulatory Affairs Associate
4 weeks ago
**About Symbiotic AI**
Symbiotic AI is changing how health care professionals and artificial intelligence work harmoniously to improve healthcare. We develop cutting edge software solutions that help improve health care decisions and outcomes. Our team is made up of passionate individuals from the field of health care, data science, and digital health.
**About the Role**
We are seeking a skilled and detail-oriented Quality Assurance and Regulatory Affairs Associate to join our expanding team. In this role, you will play a crucial part in ensuring the quality and compliance of our digital health products. Collaborating with cross-functional teams, including product development and regulatory affairs, you will contribute to maintaining the highest standards in product quality and adherence to regulatory requirements. If you are detail oriented and motivated to improve the health of people, please send us your cover letter and resume to be considered for an interview.
**Responsibilities**:
- Implement and maintain quality assurance standard operating processes to guarantee the reliability and performance of our digital health solutions
- Maintain comprehensive documentation of quality assurance processes and regulatory compliance activities
- Stay abreast of regulatory requirements and updates to contribute to regulatory strategy development and execution, ensuring our products meet compliance standards
- Assist in the preparation and submission of regulatory documents to health authorities
- Develop and execute test plans, conduct testing, and ensure compliance with industry standards by generating reports on quality metrics, testing outcomes, and regulatory submissions
- Collaborate with software developers and product managers to identify and address quality issues
**Required Qualifications**:
- Bachelor's degree, equivalent, or meaningful work experience in Quality Assurance, Regulatory Affairs, or a related field
- Proven experience in quality assurance within the healthcare or digital health industry
- Familiarity with regulatory affairs processes, requirements, and standards such as ISO 13485 and 14971, risk management systems, quality management systems
- Strong analytical and problem-solving skills
- Detail-oriented with excellent organizational and documentation abilities
- Effective communication skills for collaboration with cross-functional teams
**Experience with the following is an asset**:
- Artificial intelligence enabled medical devices
- Regulatory submissions for digital health products
- Quality assurance in a digital health or healthcare technology context.
**What we offer you**:
- Competitive compensation packages
- Professional development and growth opportunities
- Option to work hybrid remote after onboarding
- Paid time off
- Wellness benefits
- Equipment and tools required for you to succeed in your role
**Equal Opportunity Employer**
Symbiotic AI is committed to fostering an inclusive, equitable and accessible work environment. Our company is dedicated to building a team that reflects the diversity of our community, including those with disabilities. Symbiotic AI is committed to providing accommodations in all parts of the hiring process in accordance with provincial legislation. If you require an accommodation, please contact us and we will work with you to meet your needs.
We thank you for your interest in this role. Only applicants that have been selected for an interview will be contacted.
**Job Types**: Part-time, Fixed term contract, Freelance, Internship / Co-op
Contract length: 24 months
**Benefits**:
- Casual dress
- Company events
- Flexible schedule
- On-site parking
- Paid time off
- Stock options
- Work from home
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Calgary, AB T2L 1Y8: reliably commute or plan to relocate before starting work (required)
Application question(s):
- Do you have experience implementing and developing standard operating processes based on ISO 13485 and 14971?
**Education**:
- DCS / DEC (preferred)
Work Location: Hybrid remote in Calgary, AB T2L 1Y8
Application deadline: 2024-04-15
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