At a Glance
- Tasks: Research and compile technical documents for medical device regulatory submissions.
- Company: Join Wellnest, a leader in medical device innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities to lead and innovate.
- Why this job: Make a difference in healthcare by ensuring compliance and safety of medical devices.
- Qualifications: 2-5 years experience in regulatory affairs and knowledge of ISO standards.
The predicted salary is between 49500 - 60500 $ per year.
Medical device regulatory submissions require technical writing and compliance expertise at Wellnest.
Support USA, Canada, and Europe submissions while managing regulatory requirements.
As a Regulatory Affairs Specialist, you will research, write, analyze, edit, and compile technical documents for country-specific submissions.
You will communicate requirements across departments, support manufacturing processes, and address regulatory authority inquiries.
The work includes device incidents, labels, promotional materials, audits, and applicable guidance.
Key Responsibilities
- Research and compile technical regulatory submission documents
- Support manufacturing process setup and model changes
- Prepare responses to regulatory authority questions
- Assess device incidents and submit reportable events
- Review labels and promotional materials for compliance
Requirements
- Two to five years of experience
- Knowledge of manufacturing licensing and CDSCO
- Experience with applicable ISO standards
- Ability to lead startup regulatory processes independently
- Medical device approval experience is an advantage
Apply regulatory writing, compliance, manufacturing, and incident assessment skills across Wellnest medical device submissions.
Medical Device Regulatory Affairs Specialist in Ottawa employer: Wellnest Health Monitoring Pvt. Ltd.
Wellnest Health Monitoring Pvt. Ltd. is dedicated to transforming the medical device industry by ensuring compliance with regulatory standards across the USA, Canada, and Europe. The company fosters a collaborative work environment where passionate individuals can contribute to innovative solutions in health monitoring. Employees have opportunities for professional growth through hands-on experience in regulatory affairs and quality assurance.
Contact Details:
Wellnest Health Monitoring Pvt. Ltd. Recruitment Team
