Associate – regulatory affairs

Canadian Blood Services’ Quality and Regulatory Affairs Team based in Dartmouth, NS is inviting applications from suitable candidates for the position of Associate. Canadian Blood Services’ Quality and Regulatory Affairs team ensures compliance with safety and regulatory standards in blood and biologics. It provides quality assurance, internal audits, and regulatory oversight to maintain product integrity. The team works closely with federal regulators to uphold industry standards and ensure public trust. The candidates selected for the vacancy will be required to start the work as soon as possible.

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Job Description:

Employer Name: Canadian Blood Services
Team: Quality and Regulatory Affairs Team
Position: Associate – regulatory affairs
No of Vacancies: 4
Salary: $78895.00 – $92638.00 yearly
Employment Type: Regular/Full time
Classification: PTS/MGT/IT B
Job Category: Quality and regulatory affairs
Location: Dartmouth, NS
Shift: 37.5 hours per week
Reference Number: 6972

Requirements:

Languages: Candidates must have knowledge of the English Language
Education: Candidates should have completed post-secondary education from a recognized institution, preferably a bachelor’s degree in science biology, chemistry, microbiology, immunology, or medical technology
Experience: Candidates should have a minimum of 2 years of regulatory experience, with knowledge of domestic and international regulatory requirements related to fresh blood products, stem cells, tissues, and organs

Physical Requirements:

• The candidates should be able to work in a hybrid environment, with an on-site requirement at a Canadian Blood Services location 40% of the time
• The candidates should be able to work Monday to Friday, 37.5 hours per week, with a standard 7.5-hour workday, and be available for additional hours as needed based on project requirements
• The candidates should be able to travel every 6 to 8 weeks for team meetings, inspections, and project-related tasks

Other Requirements:

• The candidates should have an understanding of accreditation requirements for patient testing, stem cells, and cord blood
• The candidates should have a thorough understanding of Good Manufacturing Practices and strong organizational, time-management, analytical, problem-solving, and decision-making skills, with the ability to work within cross-functional teams
• The candidates should be inquisitive, with the ability to actively listen, question concepts, and summarize discussions effectively
• The candidates should have strong verbal and written communication skills, with proficiency in writing and editing technical documentation for diverse audiences
• The candidates should demonstrate respect for the sensitivity and confidentiality of documents received and reviewed

Responsibilities:

• The candidates should be able to assist in the development, implementation, and continuous improvement of the national reporting process related to reporting, licensing, and inspections
• The candidates should be able to leverage analytical skills, attention to detail, and technical communication abilities to develop, review, and evaluate regulatory filings
• The candidates should be able to utilize knowledge of Good Manufacturing Practices (GMP) and experience in regulatory environments to review change requests and interpret industry regulations and standards
• The candidates should be able to participate in the review and completion of accreditation submissions based on accreditation requirements
• The candidates should be able to coordinate regulatory and non-regulatory inspections by applying GMP experience and effective collaboration skills
• The candidates should be able to assist in defining, collecting, analyzing, and reviewing performance monitoring metrics to support continuous improvement

Benefits:

• The candidates will get health, dental and vision benefits for you and your family, Defined benefit pension plan, Employee discounts, wellness program, professional resources

How to apply:

If the position is fit for you and the basic requirements are fulfilled then you can now apply directly to the employer (along with your resume and reference number) through the below-mentioned details.

Apply Online