Staff Specialist, Regulatory Affairs

. Report directly to the Senior Manager of Regulatory Affairs .

Posted 10/27/2026full-timeRemote • CanadaLead💰 CA$85,000 - CA$135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing global regulatory strategies for medical devices, including compliance with FDA Medical Device Regulations and EU-MDR. Proven ability to lead regulatory efforts, mentor talent, and drive continuous improvement in processes and customer satisfaction.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Medical Device RegulationsEU-MDR ComplianceRAPS RAC CertificationRegulatory Strategy Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentTechnical File CreationRegulatory Impact AssessmentsProject ManagementSaMD Knowledge

Soft Skills

Excellent Communication SkillsStrong Organizational SkillsCollaboration and TeamworkProblem-SolvingAdaptability

Tools & Technologies

SAPRIMMS WordMS ExcelMS PowerPointMS Teams

Certifications & Qualifications

RAPS RAC Certification

Industry Keywords

Medical DevicesRegulatory ComplianceQuality Management SystemsGlobal Regulatory StrategyDesign-Control Changes

About the role

Key responsibilities & impact

Report directly to the Senior Manager of Regulatory Affairs
Support MMS Dispensing products, including non-Medical and Medical Devices, associated Software, and Accessories, globally from a Regulatory Affairs standpoint
Develop and execute global regulatory strategy for new product development, sustaining, and end-of-life activities
Monitor and interpret current and new regulatory requirements and international standards for the U.S. and rest of world
Lead regulatory efforts to comply with new and existing regulations, including FDA Medical Device Regulations and EU-MDR
Problem-solve and escalate regulatory and compliance issues to senior management as necessary
Provide effective communication and quick responses to internal customers
Drive continuous improvement in internal processes and customer satisfaction
Identify, develop, and mentor high-performing regulatory talent
Assure QSMR requirements are followed and executed consistently from a Regulatory Affairs perspective
Execute Technical File creation and remediation in collaboration with cross-functional teams
Draft and execute comprehensive regulatory impact assessments for design-control changes to existing products
Perform other duties and assignments as required

Requirements

What you’ll need

Bachelor’s degree in biology, engineering, or another science-related discipline required
Minimum of 5–7 years of directly related Regulatory Affairs experience in medical devices required
Focus on SaMD strongly preferred
RAPS RAC certification preferred
Knowledge of Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
Digital literacy in MS Word, Excel, PowerPoint, and Teams
Project Management experience
Excellent verbal and written communication skills, with strong attention to detail
Strong organizational, project, and submission management skills
Ability to prioritize multiple activities and meet competing deadlines
Strong collaboration and teamwork skills
Ability to lead and influence without direct authority
Strong regulatory strategy development skills
Flexible and adaptable, with the ability to respond effectively to changing business priorities
Functional and technical knowledge with a demonstrated ability to achieve goals successfully

Benefits

Comp & perks

Comprehensive Total Rewards program
Reward and recognition opportunities
Competitive package of compensation and benefits programs
Workplace accommodations considered pursuant to applicable law
Remote work arrangement indicated for this position
Flexible work-life balance recognized by the employer