Opportunity: Director, Regulatory Affairs and Quality Assurance
Organization: Aifred Health
Location: Montreal, Quebec
About Aifred Health:
Aifred is focused on clinical decision support in mental healthcare, starting with depression. Depression affects over 300 million people worldwide. Physicians currently have few tools to help them effectively select and manage mental health treatments based on the unique characteristics of their individual patients leading to an arduous and lengthy “trial and error” approach to treatment. Aifred operationalizes best-evidence guidelines, together with AI-based insights, to support better treatment management, and matching of individual patients to the right treatment.
Aifred plans to encompass a broad spectrum of mental health conditions, leveraging their treatment-agnostic AI model. At its core, Aifred is focused on bringing better mental healthcare to all.
Aifred is a proud official IBM Watson AI XPRIZE semi-finalist team.
The ideal candidate is a pragmatic QA/RA leader who can develop and refine processes as we scale, while maintaining compliance in an evolving regulatory environment.
Reporting to the CEO, the Director is responsible for the implementation, maintenance and improvement of the Quality System processes, in compliance with applicable SaMD standards and regulatory requirements and managing all aspects of regulatory strategy, compliance and communication with the FDA and Health Canada including preparation of regulatory submissions. Prepare and maintain product and facility registrations and device listings as required. Maintain regulatory files, consistent with regulatory requirements. Report to management on performance measures for quality improvements and regulatory compliance and provide knowledge and support to the company to enable company to operate within regulatory guidelines on an ongoing basis by keeping current with current and planned future regulatory requirements.
Supervisory and Leadership Responsibilities
- Direct, mentor and guide staff and consultants
- Foster a culture of quality within the organization
- Exhibit skills in project management, leadership, communication, and presentations
- Identify issues and minimize regulatory risks through creative problem solving
Quality Management Systems
- Responsible for the Document Control process and the efficient control of all documentation required by regulatory agencies
- Ensure the establishment of and compliance with risk management processes complying with ISO 14971
- Risk analysis (Identification and quantification of risk) and risk management (mitigation)
- Establish internal procedures and record keeping and align it with the current processes to ensure there are no redundancies or duplication of work in other areas
- Maintain all internal procedures to ensure quality control in all stages
- Develop internal documentation and training to ensure all departments, employees and management are aware of the processes and procedures required to obtain and maintain ISO certification
- Do periodic internal audits to ensure all employees and management are adhering to the requirements
- Obtain all necessary regulatory registrations, approvals, certifications, or other documents required to obtain and maintain ISO 13485-2016, MDSAP and FDA registration to facilitate the sale of the SaMD in Canada and in the United States.
- Function as the Company’s Management Representative as defined by ISO 13485:2016
- Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Author regulatory submissions and assessments for Class II medical devices to be distributed in the US and Canada to ensure timely global commercialization of products in compliance with applicable regulations and standards.
- Prepare documentation to support product registration in North America and to support future partners regulatory work internationally.
- Directly communicate with US FDA and Health Canada in preparing responses to submissions and in support of agency audits.
- Participate on new product development teams
- Review and approve new product development and product modification documentation.
- Write, review and revise company Quality System procedures as required.
- Ensure personal and company compliance with all applicable regulations, policies, and procedures.
- Act as the Person responsible for regulatory compliance in accordance with regulations in Canada and the U.S.
Education, Work Experience & Competencies:
- Minimum of 10 years of Quality Management, Quality Assurance and Regulatory Affairs leadership experience in the medical device industry, with responsibilities for managing others.
- Experience with FDA and Health Canada device and facility registrations.
- A four-year degree (an emphasis on health science would be a plus) or demonstrated proficiency through Regulatory Affairs Certification (RAC).
- Position acts independently to determine methods and procedures on new assignments.
- Job requires extensive knowledge and many years of experience, with the incumbent often reviewed as the most knowledgeable person on this subject in the company.
- Ability to read, understand and interpret medical device, FDA and Health Canada regulations and requirements. Excellent communication skills required, written and verbal. Write procedures; perform presentations to staff and management.
- Position presents training to all employees on U.S. FDA Quality System regulations, ISO 13485, and updates management on new regulatory issues.
- Expertise in personal computer application software, such as word-processing, Excel and SharePoint
- Ability to read, understand and interpret contractual agreements, patents, legal documents, advance technical articles, and professional scientific and dental journals.
- Strong Quality and regulatory knowledge
- Advanced knowledge of applicable SaMD standards and regulatory requirements (Health Canada and FDA): ISO 13485:2016, 21 CFR Part 820, ISO 14971:2019, IEC 62304:2006 + 2015: AMD1:2015 CSV and SOR/98-282
- Strong technical writing skills
- Excellent communication and organizational skills
- Able to work with minimal of supervision, with excellent organization and time management skills
- Strong attention to detail
About Pender & Howe:
Aifred has retained Pender & Howe to lead the recruitment initiative for the Director, Regulatory Affairs and Quality Assurance position.
Pender & Howe is a boutique retained executive search firm specializing in collaborating with governing boards and CEOs in identifying world class executive leaders. More information about Pender & Howe is available at www.penderhowe.com.
This search is led by Celine Chabee and Glenn Lesko. For consideration, please email a copy of your CV in confidence to Celine Chabee at [email protected].