Quality Regulatory Affairs Manager

THE COMPANY

Founded in 1994, Theralase Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”) division designs, manufactures and markets proprietary and patented super-pulsed laser technology, used to eliminate pain, reduce inflammation and accelerate tissue healing. Theralase has sold thousands of laser systems internationally to licensed healthcare practitioners to successfully treat millions of patients for hundreds of nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) division researches and develops custom designed molecules called Photo Dynamic Compounds (“PDCs”), which have demonstrated preclinically an ability to localize to cancer cells and then, when light activated, destroy the cancer cells, without affecting healthy tissue potentially leading to a higher quality of life for patients and little to no side effects, if proven clinically.

THE ROLE

The successful candidate will have 5+ years of documented experience in compiling and defending documentation for regulatory submissions to Health Canada (“HC”), the Food and Drug Administration (“FDA”) and Conformite Europeen (“CE”) to successfully achieve regulatory approvals to market medical devices / pharmaceutical drugs in the respective jurisdictions. The successful candidate will be responsible for reviewing, optimizing, implementing and supporting the Quality Management System (“QMS”) and Medical Device Directive (“MDD”) of the Company, acting as the Quality Manager and Internal Auditor for ISO-13485, Canadian Standards Association (“CSA”), Underwriter’s Laboratory
(“UL”), HC, FDA and CE audits. The successful candidate’s proven experience will allow them to carefully execute on a detailed regulatory strategy, coupled with their strong written and oral communications, knowledge of regulatory rules and regulations, excellent interpersonal skills, drive to succeed and natural leadership to achieve regulatory approval for the Company quickly and effectively.

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 / pharmaceutical drugs in the respective jurisdictions.
• Review, optimize, implement and support the QMS and MDD of the Company, acting as the Quality Manager and Internal Auditor for ISO-13485, CSA, UL, HC, FDA and CE audits.
• Update the QMS and lead the transition to ISO-13485:2016 MDSAP standard
• Ensure the company is fully compliant with ISO 13485:2016, MDD, HC Medical Device Licence and FDA rules and regulations
• 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 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 of product and processes
• Lead Corrective and Preventative Actions (“CAPA”) process and implementation of CAPA both internally and as required with suppliers
• Provide training to engineering, production, finance and administration teams to ensure understanding and compliance with HC, FDA, CSA, UL, ISO and CE quality standards
• Host and lead monthly quality meetings with engineering, production, finance and administration teams to ensure compliance to HC, FDA, CSA, UL, ISO and CE quality standards
• Audit 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

SKILLS AND QUALIFICATIONS REQUIRED

• University education with a B.E.Sc degree in engineering (electrical / mechanical discipline) or B.Sc. Life Sciences
• Certified Quality Engineer Certificate
• 5+ years’ experience in a Quality Assurance / Regulatory role in a medical device manufacturing facility, in compliance with ISO-13485
• 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 (Office, Excel, Outlook, Word, Power Point)
• Excellent oral, written and presentation communication skills with an ability to produce and defend effective regulatory submissions
• 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 the engineering and production departments
• Polished individual who remains calm and focused under pressure
• Deadline orientated with a can-do mentality to meet tight deadlines.
• Personally committed to focus, deliver and be accountable for their 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 modifications to strategy and implement positive changes effectively and efficiently

COMPENSATION

To be determined commensurate with experience + performance bonus + benefits + stock options

Reports to: VP of Engineering

If this sounds like you, apply now to be considered.

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:
wembree@theralase.com