Position Purpose: The purpose of this position is to implement and monitor quality management system and regulatory strategies for maintaining compliance with established standards and agency guidelines like ISO 13485:2012, Health Canada, US FDA etc. Also act as a QA/QC inspector to support Canada business.
Summary of Responsibilities:
Support product receiving and release for sales. Develop procedures related to product importation to Canada. Prepare and monitor product conformity and stability program. Develop and implement QA and RA strategies. Implement quality system and regulatory procedures and initiatives in to achieve compliance with regulatory requirements. Coordinate and lead internal and external audit Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements, and business process improvement initiatives. Responsible for creation, preparation, and achievement of regulatory submissions / renewal and approvals to introduce new products in Canada and other markets.
- Plan for product testing as necessary and support product receiving and release for sales.
- Develop procedures related to product importation to Canada.
- Prepare and monitor product conformity and stability program
- Develop documents used in good manufacturing practices; monitor audits of quality control areas.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
- Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
- Manage non conformance, corrective action preventive actions and deviation.
- Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations.
- Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), Technical Files, Canadian products (Drug, NHP and Device) License Applications, and internal "Letters to File".
- Support Regulatory submissions / renewal and on-going regulatory compliance for product development process.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product and manufacturing changes for compliance with applicable regulations.
- Prepare submissions including design and manufacturing changes and labeling.
- Prepare test protocols to support regulatory submissions.
- Update Risk Management files and provide input in design verification, design validation, shelf life studies.
- Provide technical guidance and training / mentoring to other QA employees and cross-functional teams.
- Develop and implement departmental and divisional policies and procedures.
- Review completion of warehouse logs for accuracy and completeness
- Review return product and contact QA Santa Rosa for disposition
- Organize and maintain documents and records on file and electronically
- Bachelor or Master in Science (Preferred technical field)
- A Diploma in Regulatory Affairs or RAC designation (Preferred)
- Knowledge of Health Canada regulations
- Knowledge of FDA regulations, guidance, and import/exports requirements.
- Knowledge of European Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
- Knowledge in product labeling and promotional requirements.
- Strong understanding of the quality system requirements
- Thorough knowledge of product development process, design control and Quality Systems.
- Strong technical knowledge of Drugs, Natural health and medical device products.
- Minimum 5 to 10 years of QA / RA medical industry experience.
- Demonstrated success in Quality management.
- Knowledge or experience in Risk management
- Knowledge of QS and Regulatory regulations preferred.
- Statistical analysis and problem-solving ability strongly preferred
Skills & Requirements
- Able to lead internal and external inspection and able to prepare and submit the audit response to Inspectors
- Proficient in timely review of technical and clinical data.
- Proficient in Health Canada, US FDA and international regulations
- Technical knowledge of Drugs, Natural health and medical devices.
- Good presentation skills.
- Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel
- Strong written and oral communications skills
- Detail oriented and Self-motivated.
- Capability and commitment to working both independently and as part of a team.
- Excellent negotiation and problem solving skills
- Ability to write clear, concise, and well thought out technical documents.
- Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills
- Ability to work under minimal supervision and independently.
- Must be able to work in a timeline-driven environment.
How to Apply
Send resume to firstname.lastname@example.org