15 Pharmaceutical Safety jobs in Canada
Manager, Regulatory Affairs - IVD
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Job Description
Title: Manager, Regulatory Affairs (IVD)
Location: Greater Vancouver On-Site
Position: Permanent, Full-Time
Workplace Type: On-site
Reports To: Director
Salary Range: $90,000 to $100,000 per annum
Position Overview:
Join a growing IVD company as Manager, Regulatory Affairs (IVD). With your 6+ years of IVD experience and RAC certification, you will lead regulatory strategies and submissions to support global market approvals for diagnostic medical devices. Responsibilities include preparing submissions (510(k), CE, Health Canada, WHO, etc.), overseeing product licensing, complaint handling, post-market surveillance, labeling, and change notifications. You will manage regulatory staff and collaborate cross-functionally with leadership, product development, and quality teams.
Key Responsibilities:
- Regulatory Leadership:
- Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k))
- Act as the primary liaison with regulatory agencies
- Management and mentor a regulatory team
- Compliance & Strategy:
- Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.)
- Proven leadership, project management, and communication skills
- Monitor regulatory changes to assess impacts on products
- Oversee product licensing, labeling, complaints, and post-market surveillance
- Collaboration & Mentorship:
- Partner with R&D, Quality, and Operations teams to ensure market readiness
- Mentor junior staff and review work for compliance
- Process Improvement:
- Optimize regulatory workflows and documentation processes
Qualifications:
- Education: Bachelor's in Life Sciences, Biotechnology, RAC preferred
- Experience:
- Required 6+ years in Regulatory Affairs, with specific experience working in IVDs.
- Proven experience with global submissions (e.g. De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).
- Proven leadership, project management, and communication skills
- Authority to work in Canada.
Perks:
- Competitive salary
- Health and dental benefits, paid sick days, birthday off
- Free parking, on-site gym, and a dynamic workplace culture
What's Offered:
This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.
To Apply:
For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at . To apply, please use the TalentSphere job board.
TSSHP LI-TS1
LI-TS1
Job Posting ID: #16648708
Senior Manager, Clinical Quality and Safety
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Company Description
Here’s your opportunity to join a growing company in the rapidly evolving health care sector. Spectrum Health Care is currently seeking a clinical professional with expertise in quality improvement, risk management and patient safety to join our Clinical Quality, Outcomes and Education team. The successful candidate will be responsible for leading and overseeing the development and implementation of quality improvement, risk management, patient safety, and outcome measurement strategies across our organization.
With over 40 years of experience delivering innovative home health care and specialized services, Spectrum Health Care is blazing a trail of positive health system change. If you are a clinical quality and safety leader with a commitment to continuous improvement, we want you on our team.
Job Description- Provides quality improvement leadership by developing, implementing and managing corporate-wide clinical quality improvement programs, to ensure the delivery of high-quality patient care.
- Responsible for risk management and mitigation strategies
- Leads the development and implementation of patient safety initiatives including incident reporting systems and root cause analysis. Ensures timely and effective identification, escalation and resolution of significant clinical risks and compliance gaps.
- Oversees the collection, analysis and reporting of clinical outcomes data to monitor performance and identify areas for improvement. Works closely with interdisciplinary teams to implement quality initiatives.
- Ensures that all clinical practices comply with professional practice standards and stays up to date on changes in healthcare regulations and standards, implementing adjustments to policies and procedures and guidelines in alignments with best practices in home care quality and safety.
- Works with internal and external stakeholders including health care providers, patients and regulatory agencies to promote quality safety and risk management initiatives.
- Represents the organization in quality, safety and risk management forums and contributes to the development of excellence in industry standards for homecare quality and safety
- Education: Bachelor’s degree in Nursing, Public Health, Health Administration, or a related clinical discipline. (Master’s degree preferred)
- Experience: Minimum of 5 years’ experience in clinical quality improvement, risk management, patient safety, or a related area within healthcare
- Proven experience in leading quality improvement initiatives, managing patient safety programs, and overseeing risk management activities ( in home care, community health preferred)
- Proficiency in using QI tools and software
- Strong knowledge of regulatory, professional practice requirements and accreditation standards in the homecare sector
- Experience with data analysis and evaluation, performance measurement, and benchmarking
- Preferred Certifications:
- Certified Professional in Healthcare Quality (CPHQ)
- Certified Professional in Clinical Risk Management
- LEAN, Six-Sigma, or other QI Methodologies are an asset.
- Healthcare Quality or Patient Safety
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