The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
The Senior Regulatory Affairs Associate will join a fast-growing medical technology company in a position that handles regulatory approval and compliance. You will assist in providing support for new safe and effective products to be released on the market. You will also ensure that Intellijoint is prepared for changes to global medical device regulations.
As a snapshot, we are looking for someone who:
Possesses regulatory experience in a regulated environment related to electrical/electronic and/or software medical devices.
Has compiled and submitted a regulatory submission for a Class II/III/IV product.
Has knowledge of domestic and international medical device regulations.
Assist in managing and maintaining regulatory approvals and licences for Intellijoint products.
Perform industry research to assist in the development of an informed global regulatory strategy.
Author regulatory submissions to gain approval for new products and changes to existing products in global markets.
Liaise with Health Canada, the FDA, and other international regulators and Sponsors.
Prepare regulatory assessments for new products and changes to existing products to inform development and improvement activities.
Communicate and contextualize regulatory and quality requirements for consideration in design change projects and communicate determinants to management, as required.
Provide regulatory support on cross-functional projects.
Review and approve relevant technical documents including product Design History File documents, Engineering Change Orders, marketing materials, etc.
Support post-market activities such as complaint monitoring, adverse event reporting, field actions, recalls, etc.
Create and maintain regulatory procedures and records.
Operate within all Intellijoint processes and procedures.
Manage time sensitive, fact finding requests from various departments.
Skills and Experience:
Degree in Engineering, Science or related disciplines
Post-Graduate diploma in Regulatory Affairs is an asset
Experience compiling and maintaining regulatory submissions (510K, Medical Device Licence applications etc.)
Experience interfacing with Regulatory Agencies
Knowledge of domestic and international regulations (Canada, US, Europe, Australia, Japan)
3-5 years of working regulatory experience in an electrical/electronic and/or software medical device environment
Technical system skills (e.g. MS Office applications, regulatory databases, efficient online research)
Immense attention to detail and technical writing capabilities
Internal Number: 01
About Intellijoint Surgical
The Company’s proprietary core technology, Intellijoint HIP™ and Intellijoint KNEE™ are miniaturized surgical grade tracking systems placed within the sterile field. These are unique medical smart tools that assists surgeons with accurate selection, positioning and alignment of implants during joint replacement surgery.