Director Quality Assurance Regulatory Affairs

Biotech Partners; Halifax; On-site; CAD 110,000 - 150,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a strategic Director of Quality Assurance & Regulatory Affairs to drive quality and compliance at their Halifax facility. The role requires extensive experience in IVD and biologics manufacturing, coupled with leadership in regulatory strategy and quality management to maintain high compliance standards.

Qualifications

• Minimum 10 years of experience in Quality Assurance and Regulatory Affairs.
• At least 5 years in a leadership capacity.
• Direct experience with Health Canada, FDA, ISO 13485 regulations.

Responsibilities

• Lead development and implementation of the Quality Management System (QMS).
• Oversee internal and external audits and regulatory inspections.
• Manage product release, batch records, change control, and CAPAs.

Skills

Leadership

Organizational Skills

Communication

Education

Bachelor’s or Master’s degree in Biology, Biochemistry, or related field

Job description

Director Quality Assurance Regulatory Affairs

Director Quality Assurance Regulatory Affairs

We are seeking an experienced and strategic Director of Quality Assurance & Regulatory Affairs (QA / RA) to lead quality and compliance efforts at our Halifax-based facility. The ideal candidate will have a strong background in IVD (in vitro diagnostics) , blood typing reagents , or biologics manufacturing , and will be passionate about maintaining the highest standards of regulatory compliance and operational excellence in a regulated environment.

Key Responsibilities

Quality Assurance (QA)

• Lead the development, implementation, and continual improvement of the Quality Management System (QMS) in accordance with ISO 13485, CMDR, and other applicable regulations.
• Oversee internal and external audits , including Health Canada and international regulatory inspections.
• Manage product release , batch records , change control , CAPAs , and non-conformances .
• Ensure appropriate validation of processes , equipment, and analytical methods.
• Provide leadership and mentorship to the QA team; ensure training and compliance throughout the organization.

Regulatory Affairs (RA)

• Develop and execute global and domestic regulatory strategies for product submissions and approvals (e.g., Health Canada, FDA, EU IVDR).
• Prepare, review, and submit regulatory dossiers , renewals, and post-market surveillance reports.
• Ensure regulatory compliance for labeling, advertising, and promotional materials .
• Maintain up-to-date knowledge of changes in regulatory landscapes and assess impact to current operations and products.

Qualifications

• Bachelor’s or Master’s degree in Biology, Biochemistry, Medical Laboratory Science , or a related field.
• Minimum 10 years of experience in Quality Assurance and Regulatory Affairs , with at least 5 years in a leadership capacity .
• Direct experience with Health Canada , FDA (21 CFR Part 820) , ISO 13485 , and ideally EU IVDR regulations.
• Demonstrated experience in a manufacturing environment producing biologics, diagnostics, or similar regulated products.
• Strong understanding of risk management (ISO 14971) and design control .
• Excellent organizational, communication, and leadership skills.
• Certification(s) such as RAC, ASQ CQA, or related credentials are considered an asset.

Preferred Experience

• Familiarity with transfusion diagnostics , blood grouping reagents , or specialty immunohematology products.
• Experience working within a global regulatory framework and cross-functional environments.
• Knowledge of Good Manufacturing Practices (GMP) for biologics or IVDs.

Seniority level

Seniority level

Director

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance and Management

Biotechnology Research, Hospitals and Health Care, and Medical Equipment Manufacturing

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