A. General Summary
MolecuLight is a start-up company in Toronto, specializing in point-of-care diagnostic imaging, developing handheld optical imaging platforms. MolecuLight’s first product is an imaging system with primary applications in bacterial imaging for wound care.
MolecuLight is seeking an experienced Regulatory Affairs Specialist to join their downtown office. The role involves managing the regulatory activities for the business.
Reporting to the CEO, the Regulatory Affairs Specialist will perform activities required to ensure regulatory acceptance and compliance for markets the company may wish to enter into.
Key responsibilities include: developing notifications and submissions to regulatory agencies for commercial market approval and for clinical investigations, ensuring that project documentation and activities will comply with standards and guidances required by regulatory agencies, assisting as required to ensure compliance with regulations unrelated to product development, such as workplace safety, electronics recycling, etc.
B. Key Accountabilities and Responsibilities
› Work with our Regulatory partners to assist in developing Regulatory strategies for development projects for the US, EU and Canadian markets.
› Develop submissions to regulatory agencies required to allow product to be shipped to U.S., European, and Canadian markets
› Monitor regulatory agencies for changes in policies and procedures and report all necessary information to the VP, Quality Assurance and Regulatory Affairs
› Maintain knowledge about applicable standards, directives and guidances necessary to facilitate notifications and submissions to regulatory agencies
› Develop quality system documentation (such as procedures and work instructions) to address new and updated standards and guidances, as required
› Assist as required during clinical trials in accordance with rules mandated by regulatory agencies
› Advise of any ideas for the improvement of processes
› Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
› Other duties as directed by, VP, Quality Assurance and Regulatory Affairs and/or Manager, Quality Assurance
The position reports directly to the CEO.
Internally, the Regulatory Affairs Specialist shall work as required with Project Team Leaders and subject matter experts (SMEs) from various departments to ensure that correspondence provided externally is accurate and complete.
Externally, the Regulatory Affairs Specialist works with regulatory agencies, international representatives, investigators, research ethics boards (or IRB), and other organizations as required.
D. Knowledge, Skills, and Experience Preferred
› BS degree in Science/Engineering or related field.
Knowledge and Experience preferred in the following (or related) practices:
› 5-7 years’ experience working directly with regulatory bodies in the medical device area.
› Knowledge of quality and regulatory standards
› Experience with all aspects of the development lifecycle
› Medical device commercialization experience is an asset
› Medical device development experience is an asset
› Medical device software standards
› Experienced in developing submissions for regulatory agencies
› Excellent English communication skills, both verbal and written
› Excellent organization, documentation and prioritization skills
› Knowledge in medical device systems
› Must be willing to learn
› Sound understanding of Quality Assurance methods
› Ability to prepare high quality and reliable deliverables
› Ability to work independently, including managing schedules for concurrent projects
› Ability to accurately interpret and follow standards and guidances
› Ability to follow up on issues without guidance
› Ability to respond to urgent situations appropriately by prioritization
› Accuracy and strong attention to detail
The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.