Head of Quality and Regulatory

2 weeks ago

Toronto, Canada Winterlight Labs Full time

**Job Summary**

**Role & Responsibilities**
- Ensure compliance with ISO 13485 quality standards and applicable regulatory requirements pertaining to the medical device industry (FDA, Health Canada, and foreign markets)
- Coordinate, prepare, review, and implement new SOPs and ensure ongoing staff training
- Manage the CAPA system, which involves issuing recommendations for corrective and preventive actions necessary to ensure conformity with quality specifications and identifying and implementing improvements to the QMS
- Work effectively with the Product and Engineering teams to develop process control and validation protocols
- Where required, lead and/or assist management representatives in preparing for any internal and external audits
- Lead and manage QMS implementation and maintenance
- Provide leadership in preparing and developing registration and approval activities for getting Winterlight’s product to market
- Develop strategies with respect to medical device regulatory requirements, risk management, registration, and product safety testing standards
- Perform regulatory due diligence
- Proactively identify business impacts and opportunities in the regulatory environment
- Lead and manage the preparation, compilation, and assembly of submission documents to regulatory bodies including FDA, Health Canada and EU Notified Bodies
- Identify major clinical, technical, or operational risks impacting on the success of regulatory filing, approvals, labelling and maintenance
- Responsible for the development and maintenance of excellent working relationships with regulatory bodies and industry associations
- Ensure compliance with relevant laws and regulations within areas of responsibility including ISO 13485, EU Medical Device Regulation (MDR), 21 CFR Part 11, Food and Drug Administration (FDA), Quality System Regulation (QSR) 21 CFR 820, and other applicable international regulations

**Required Qualifications**
- A bachelor’s degree in a related or technical/scientific field, or experience demonstrating equivalent required knowledge and competencies
- 5-10 years of quality assurance and regulatory affairs experience
- Experience with quality systems management within the medical device or pharmaceutical industry
- Experience across QMS implementation and maintenance, software development processes, and SaMD submissions to FDA and other regulatory bodies
- Solid knowledge of: FDA regulations and regulatory activities, SOP development, GxP, FDA regulations (CFR 820), ISO standards (ISO 13485), FDA regulatory activities (510k, pre-submission, etc.), cGMP, training programs, and audits
- Excellent and applied knowledge of FDA regulations for the medical device industry

**Preferred Qualifications**
- Certification in a regulatory or quality discipline
- In-depth understanding of emerging trends and issues in the changing regulatory landscape

**Additional Information**

Winterlight Labs is a fast growing startup based in Toronto that is developing digital biomarkers to measure neurological and psychiatric conditions. Our machine learning based technology analyzes both the acoustics and content of speech and language, to help identify disease and quantify its severity. We work with life science companies, academia, and senior care companies to improve clinical trials, quality of care, and health outcomes.

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