Plan, manage, and execute compliance-focused initiatives across multiple global jurisdictions
Communicate potential risks and mitigation strategies to stakeholders
Develop detailed project plans, schedules, and resource allocation strategies while ensuring compliance objectives are met
Serve as liaison between Quality, Regulatory Affairs, Operations, IT, and Product Management to ensure seamless execution of cross-functional initiatives
Lead project meetings, provide status updates, and communicate risks and mitigation plans to stakeholders and senior management
Track project milestones and deliverables
Collaborate with cross-functional teams to integrate compliance requirements into business processes
Develop and deliver strategic compliance training programs to ensure cross-functional awareness and accountability
Act as a key member of the leadership team, contributing to the company's compliance strategy and overall quality initiatives
Design, implement, and maintain the supplier qualification program in accordance with global compliance requirements (FDA, Health Canada, EMA, and TGA)
Lead the qualification and onboarding process for new suppliers, including audits, technical assessments, and quality risk evaluations
Establish and monitor supplier performance metrics
Maintain up-to-date knowledge of relevant global regulatory requirements and industry best practices related to supplier management
Develop and implement a regulatory strategy for market entry in Europe.
Requirements
Bachelor's degree in Science
Minimum five (5) to seven (7) years in a senior/responsible role within Quality, Compliance, or Regulatory Affairs, and a total of 10 years' professional experience
Knowledge of FDA, Health Canada, TGA, and EMA regulations
Knowledge of project management
Proficient in Microsoft Office (Word, Outlook, and Excel) required
Experience with Creatio and MasterControl is an asset
Fluent in French and English (spoken and written) required
Strong writing skills
Reliable, accountable, and detail-oriented
Organized with strong judgment and decision-making abilities
Benefits
Work–life balance – 37.5-hour workweek with early-finish Fridays year-round, paid time off and vacation policy
Invest in your health – Choice of modular plans, health spending account, and free telemedicine
Your well-being matters – Employee wellness program offered
Flexible work environment – Hybrid work schedule with home office reimbursement program
A promising future – Learning and career development opportunities within Medisca
Save for your future – Medisca contributes to a Deferred Profit Sharing Plan (DPSP) when you contribute to an RRSP
Help us grow – Employee referral program
Central location – Free parking/easily accessible by public transit; shopping center within walking distance for lunch or groceries
We like to have fun – Company events throughout the year.