What are the responsibilities and job description for the Senior Regulatory Specialist position at Jobgether?
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Specialist in Canada.
This role sits at the center of global regulatory strategy execution for medical device products, ensuring that submissions, approvals, and lifecycle compliance activities are delivered accurately and on time across multiple regions. You will work closely with commercial, quality, and regulatory platform teams to align regulatory pathways with business priorities while maintaining strict adherence to international standards. The position combines hands-on regulatory submissions work with cross-functional coordination, stakeholder engagement, and continuous improvement initiatives. You will also interact with regulatory authorities, helping represent the organization in a professional and solutions-oriented manner. This is a highly collaborative and impact-driven environment where precision, regulatory expertise, and communication skills directly influence product availability and patient access.
\nIn this role, you will be responsible for leading and supporting regulatory submissions and lifecycle activities across assigned regions, ensuring compliance with applicable medical device regulations while aligning with commercial and operational priorities. You will also contribute to regulatory strategy execution, data governance, and continuous improvement efforts across systems and processes.
- Prepare, submit, and manage regulatory filings for medical devices with accuracy, timeliness, and compliance.
- Develop and execute regulatory strategies in collaboration with platform regulatory and commercial teams.
- Maintain and manage regulatory licenses and product registrations across responsible countries.
- Monitor regulatory changes and trends, ensuring proactive alignment with evolving requirements.
- Support interactions with regulatory authorities, representing the organization professionally and effectively.
- Ensure regulatory data integrity across ERP, RIM, and related systems.
- Contribute to audits, inspections, and regulatory due diligence activities for acquisitions and field actions.
- Support training initiatives and knowledge sharing across teams to strengthen regulatory capability.
- Drive continuous improvement initiatives in regulatory processes, systems, and workflows.
Requirements
This position requires extensive experience in regulatory affairs within the medical device industry, with strong knowledge of global regulatory frameworks and submission processes. The ideal candidate combines technical regulatory expertise with strong communication, analytical thinking, and the ability to operate in a cross-functional, fast-paced environment.
- Bachelor’s degree in a scientific, engineering, regulatory, or related technical discipline.
- 8 years of experience in medical device regulatory submissions.
- Strong knowledge of regulatory frameworks such as ISO 13485 and design control requirements.
- Proven experience preparing and managing complex regulatory submissions.
- Excellent written and verbal communication skills, including stakeholder and authority engagement.
- Strong project management, analytical, and organizational skills.
- Ability to work collaboratively across regulatory, quality, and commercial teams.
- Detail-oriented mindset with a strong focus on compliance and accuracy.
- Ability to interpret regulatory requirements and translate them into actionable strategies.
Benefits
- Competitive compensation aligned with experience and expertise.
- Comprehensive health and wellness benefits package.
- Opportunities for professional development and continuous learning.
- Exposure to global regulatory strategy and cross-functional leadership initiatives.
- Collaborative and mission-driven work environment focused on improving patient outcomes.
- Career growth opportunities within a global medical technology organization.
- Stable, full-time role in a regulated and impactful industry.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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