Quality Regulatory Affairs Coordinator (“QRAC”) in charge of the Quality Management System (“QMS”), ISO-13485:2016, Medical Device Directive (“MDD”), Medical Device Single Audit Program (“MDSAP”) and regulatory approval of Theralase’s medical laser systems (“Products”); including: internal quality reviews, employee training, production documentation and Standard Operating Procedures (“SOPs”)
Reports to: Engineering Manager
Duties and Responsibilities:
Research, compile and defend documentation for regulatory submissions to Health Canada (“HC”), the Food and Drug Administration (“FDA”) and Conformite European (“CE”) to successfully achieve regulatory approvals to market Products in the respective countries
Review, optimize, implement and support the QMS, MDD and MDSAP of the Company, acting as the Quality Manager and Internal Auditor for ISO-13485: 2016, Canadian Standards Association (“CSA”), Underwriter’s Laboratory (“UL”), HC, FDA and CE audits.
Lead, manage and optimize the QMS to comply with ISO-13485:2016, MDD and MDSAP
Ensure the Company remains fully compliant with ISO 13485:2016, MDD, MDSAP, CSA, HC Medical Device Licence, FDA and CE rules and regulations for all of its Products
Prepare for internal audits and inspections and act as lead contact for HC, FDA, CE and ISO audits and inspections
Prepare for quarterly audits and interface directly with CSA auditors
Responsible for the review, control and release of documentation and records in support of the QMS; including maintaining the Design History File, Device History Records and Device Master Records
Develop quality metrics and provide analysis to senior management to support continuous improvement and optimization of quality of product and processes
Lead Corrective and Preventative Actions (“CAPA”) process and implementation of CAPA both internally and externally with suppliers and sub-contractors
Analyze and compile data to complete, manage and successfully close out initiated 8 Discipline (“8D”) reports
Provide training to the entire organization; specifically: engineering, production, customer service, finance and administrative teams to ensure understanding, compliance and optimization of HC, FDA, CSA, UL, ISO and CE quality standards
Host and lead monthly quality meetings with engineering, production, customer service, finance and administrative teams to ensure understanding, compliance and optimization on various aspects of HC, FDA, CSA, UL, ISO and CE quality standards
Conduct unscheduled audits of quality records of all departments to ensure compliance with HC, FDA, CSA, UL, ISO and CE quality standards and provide report to senior management on compliance and opportunities for improvement
Skills and Qualifications Required:
University education with a B.E.Sc degree in engineering (electrical/mechanical discipline). Preference will be given to candidates with a Certified Quality Engineer Certificate
5+ years’ experience in a Quality Assurance / Regulatory role in a medical device manufacturing facility, in compliance with ISO-13485:2016
Experience in successful regulatory submissions to HC, FDA and CE
Experience leading internal audits, ISO audits, HC, FDA and CE inspections.
Experience in Risk Management – ISO 14971
Computer literate in Microsoft Office environment (Office, Excel, Outlook, Word, Power Point)
Excellent oral, written and presentation communication skills with an ability to produce and defend effective regulatory submissions in a timely fashion
Independent and interdependent worker with a proven ability to achieve regulatory objectives under minimal supervision
Self-disciplined, self-motivated and professional in demeanor
Team player with a proven ability to build positive relationships at all levels of an organization; especially with senior management, engineering, production, customer service, finance and administrative departments
Polished individual who remains calm and focused under pressure
Deadline orientated with an ability to meet tight deadlines.
Personally committed to focus, deliver and be accountable for their performance and the Company’s regulatory performance
An organized individual with the ability to prioritize in a multi-tasking environment with excellent attention to detail and accuracy
Enjoys working in a challenging and fast growth environment
Demonstrated flexibility and adaptability with an ability to learn from past opportunities, analyze past performance and implement strategies to effectively improve performance
Hard working, lead by example coordinator
$50,000 to $60,000 base, commensurate with experience + performance bonus + employee benefits (after 3 months) + stock options, subject to board of director approval.
Theralase® is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Theralase® is also committed to compliance with all fair employment practices regarding citizenship and immigration status.