Senior Regulatory Specialist
New
CanadaFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 8+ years
- Required Skills
- Project Management
Requirements
- 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.
Responsibilities
- 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.
View Full Description & ApplyYou'll be redirected to the employer's site
