Quality Regulatory Affairs Coordinator

 

THE COMPANY

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions. 

Additional information is available at www.theralase.com and www.sedar.com . 

THE ROLE 

The successful candidate will have 5+ years of medical device regulatory experience in compiling, defending and successfully achieving regulatory submissions to Health Canada (“HC”), the Food and Drug Administration (“FDA”) and Conformite Europeen (“CE”) to achieve regulatory approvals to market medical devices and their respective pharmaceutical drugs in the respective jurisdictions in a timely fashion. 

The successful candidate will be responsible for: 

• Reviewing, optimizing, implementing and supporting the Quality Management System (“QMS”), Medical Device Directive (“MDD”) and Medical Device Single Audit Program (“MDSAP”) of the Company 

• Being the Quality Manager and Internal Auditor for ISO-13485: 2016 and MDSAP 

• Leading and managing all regulatory audits for Canadian Standards Association (“CSA”), Underwriter’s Laboratory (“UL”), HC, FDA and CE audits. 

• Leading, managing and optimizing compliance of the QMS to ISO-13485:2016, MDD and MDSAP rules and regulations 

• The successful candidate’s proven experience will allow them to carefully execute on a detailed regulatory strategy, coupled with their strong written, oral and presentation communications, innate knowledge of regulatory rules and regulations, excellent interpersonal skills, drive to succeed and natural leadership to achieve successful regulatory approval for the Company effectively and in a timely fashion. 

DUTIES AND RESPONSIBILITIES

• Compile and defend documentation for regulatory submissions to HC, the FDA and CE to successfully achieve regulatory approvals to market medical devices (and their associated pharmaceutical drugs for specific oncological and therapeutic applications) in the respective jurisdictions 

• 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, CSA, 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, HC Medical Device Licence, FDA and CE rules and regulations for all of its medical devices 

• Prepare for internal audits and inspections and act as lead contact for HC, FDA, CE and ISO audits and inspections 

• Prepare for quarterly CSA 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 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 reports 

• Provide training to the entire organization; especially: 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 management on compliance and opportunities for improvement 

REQUIREMENTS

• 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 

• Fully computer literate in Microsoft Office environment (i.e.: 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 management, the 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 

REPORTS TO

Production Engineering Manager 

COMPENSATION

$70,000 to $90,000 base, commensurate with experience + performance bonus + benefits + stock options 

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If this sounds like you, apply now to be considered.
This position is open until December 15, 2018.

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.

 

Apply for this position

Please submit your application to:
rwhite@theralase.com