Quality Assurance Regulatory Affairs Manager Jobs

Strong experience with HACCP, GMPs, animal care practices, regulatory submissions, SFCR documentation, and other relevant management systems.

Experience with crisis management, recall processes, ethical sourcing audits, regulatory inspections, and SFCR assessments.

Provide guidance, training, and performance management to ensure team members are equipped to meet their objectives.

Ensure compliance with industry standards (e.g., BRC/GFSI), animal welfare certifications, CFIA regulations, SFCR requirements, and customer-specific mandates.

Ensure alignment with industry best practices, evolving regulatory requirements, SFCR, and animal welfare standards.

In-depth knowledge of food safety regulations, quality standards, animal welfare principles, ethical sourcing practices, CFIA regulations, and the SFCR.

Experience working within a Quality Management System (QMS)

Strong organizational, time management, and prioritization skills.

Support system administration of Quality Management System software.

Skills and Experience to Enable Success:

A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations

Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.

Maintain all Quality Management meeting documentation.

Maintain and issue training requirements to company.

Maintain working knowledge of ISO 13485 and ISO 14971.

Maintain in depth knowledge of regulatory guidance documents.

Experience in documentation for Class II/III or IV medical devices, experience with 510(k) or De Novo Submissions a plus.

Experience with ISO 13485 or ISO 9001, experience with ISO 14971 a plus.

Support maintenance of Diva’s ISO 13485 certification and Quality Management System as a whole.

Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;

Report on performance of the QMS to top management

Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;

Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;

Ensure compliance with applicable regulatory standards/requirements;

· Organize and planning skills to effectively manage the flow of stock

· Ability to have the right mindset and attitude to freely share knowledge, knowhow, and skills

· Manages internal label documents ensuring only current and up-to-date labels are circulated.

· 4-7 years of regulatory experience in a regulatory, preferably in manufacturing environment

· Detail oriented, accurate and excellent record keeping skills

· Knowledge of Canadian and US Food Labelling Regulations is required

Excellent organization, time management and prioritization skills

Facilitate training (or train) operators and managers on quality systems and issues

Minimum 3 years’ experience with releasing drug/NHP product to the Canadian Market is preferred.

Thorough and demonstrated knowledge of ICH Guideline, FDA-CFR regulations, and other relevant policies.

Strong written and verbal communication skills.

Sound problem solving and decision-making abilities.

Understanding of ISO 13485 requirements by certification.

Strong understanding of business practices with fundamental understanding of project management methodology and administrative functions.

Support regulatory compliance/agency audit and audit related research, documentation and preparation, in accordance with business goals, regulatory compliance, and legal requirements.

Manage training profiles and training matrix for all departments.

Work with all departments to obtain an in-depth understanding of the documentation requirements.

Work in accordance with Diva International Inc.’s Quality Policy and B-Corp set of standards, ISO, GMP and FDA requirements as applicable.

Experience preparing regulatory submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices.

Management Representative; responsible for implementation, governance, performance reporting, and maintenance of Ventripoint’s quality management system.

Ensure compliance with GMPs, and applicable regulatory requirements related to product importation, release and distribution in Canada, United States, and Europe.

Manage preparation and implementation of new SOPs. Manage CAPAs, deviations, and out-of-specification investigations.

Manage preparation and review of validation protocols and reports.

Experience developing regulatory strategies and plans.

In depth knowledge of regulatory requirements, i.e., GMP, Health Canada, EU, and FDA and experience with GMP documentation review.

Designing, implementing, harmonizing and systemically reviewing the Cytiva Pharma Quality Management System (QMS), starting with PNI.

Accountable for Quality Governance, Quality Escalation and Quality Management Review processes.

Manage Regulatory and Quality personnel in accordance with Company talent management practices. Train, mentor, and coach the staff within the department

Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.

Participate in any issues that require management escalations

Experience with the concepts, principles, practices, and methodologies of policy and regulatory analysis.

Strong analytical and communication skills.

Strong project coordination and research skills.

Strong computer skills including proficiency with MS Office and other related software.

Comprehensive group benefits plan, including health/dental, life insurance, LTD, and company-matched RRSP contributions

Job Title:Manager, Health Product Regulatory Affairs