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Regulatory Affairs & Quality Assurance Director

Location:Burnaby, Greater Vancouver, British Columbia, Canada
Job Type:Permanent
Posted:8th Apr 2010
Closing Date:6th May 2010
Posted By:Artron BioResearch Inc.
Details:
Regulatory Affairs & Quality Assurance Director

Regulatory Affairs & Quality Assurance Director

Description:
This position is responsible for managing regulatory affairs, global regulatory compliance including gaining regulatory approvals in the marketing of the company’s products, and Quality Assurance.

Responsibilities:

• Ensure compliance with Canadian Health Canada Medical device and In Vitro Diagnostic Device product registration and licensing requirements.
• Ensure compliance with U.S. Food and Drug Administration (FDA) Medical device and In Vitro Diagnostic Device registration and premarket requirements.
• Ensure compliance with European MDD and IVDD requirements for Device registration and post marketing vigilance system.
• Ensure compliance with Chinese State Food and Drug Administration (SFDA) Medical device and In Vitro Diagnostic Device registration and premarket requirements, as well as CCC certificate application.
• Maintain contact with local & international regulatory bodies, such as Health Canada, FDA, European competent authorities & notified bodies, SFDA, etc.
• Independently plan and manage regulatory strategies and submissions for complex new products development and change control projects.
• Maintain current regulatory knowledge of domestic and internationals, guidelines, and standards and apply appropriate implementation strategies.
• Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
• Developing, implementing, maintaining and improving a quality management system in accordance with ISO 13485, Canadian Medical Device Regulations, European Medical Device Directives, and FDA Quality System Regulations.
• Acting as the lead QA Auditor to conduct internal audit for Quality management system with related regulations.
• Conducting external site/vendor audit.
• Provide supporting for 3rd party audit (FDA, Notified Body).
• Directs and coordinates activities and operations of quality assurance department and staff. Providing the leadership, mission and vision for Quality organization.

Qualifications/Requirements:
Bachelor's degree in Biomedical Engineering is required, advanced degree is preferred.
Minimum of 10 years work experience in the areas of medical device, which at least 5 years experience in Global Regulatory Affairs such as CE, CMDR and SFDA approval related.
Minimum 3 years supervisory experience required.
Certified training as the auditor (for ISO 9001). Certified training for CMDR & CMDCAS.
Knowledge of Canadian Medical Device Regulations, and European Medical Device Directives. Direct experience with ISO 13485, MDD, IVDD and CMDCAS auditing is preferred.
Knowledge of QMS standard likes: ISO 9001, ISO 13485, MDD 93/42 EEC, IVDD 98/79/EC, CMDCAS and also related applicable standards.
Knowledge of SFDA requirements for Medical device and In Vitro Diagnostic Device registration.
Knowledge of risk management for medical device, e.g. ISO 14971.
Knowledge of sterilization of medical device which including the validation process.
Familiarity with clinical development process (e.g. clinical protocols, issues with conducting clinical trials).
Excellent communication skills.
Strategic/tactical planning and implementation capabilities.
Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence

Fluency in Chinese (writing and speaking)


 
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