Regulatory Affairs Specialist
5 days ago
Clarion Medical Technologies is a leading company in surgical, vision and aesthetic healthcare medical devices. We specialize in laser technologies, diagnostic tools for early disease detection and advanced imaging systems.
We empower healthcare providers with the tools and expertise to deliver outstanding patient outcomes by offering a competitive salary and benefits package, including extended healthcare benefits for you and your family, paid vacation time and personal days.
The RoleThe Regulatory Affairs Associate will report to the Senior Director of Regulatory Affairs and Quality Compliance. This role requires strong analytical skills, attention to detail, and expertise in regulatory and quality management software and systems.
You will play a vital role in supporting key quality system projects, managing product documentation, and ensuring post-market compliance for our medical devices. The successful candidate will have a background in regulatory affairs and quality compliance.
Key Responsibilities:- Prepare and register regulatory submissions for new product registrations, ensuring compliance with Health Products and Food Branch (HPB) guidelines and other regulatory requirements.
- Manage scientific, medical, clinical, and manufacturing documentation related to product registration and quality compliance.
- Facilitate eQMS records for product changes, government requests, and affiliate interactions.
- Lead key quality system projects, including complaint handling, traceability, technical file/batch work processing, and receiving inspections.
- Ensure suppliers provide documentation and responses within specified limits, adhering to regulatory and quality standards.
- Bachelor's degree (BA) in Life Sciences, Medical Technology, Regulatory Affairs, or a related field.
- Minimum of 3 years of experience in a regulatory affairs or quality compliance role, preferably within the medical device or pharmaceutical industry.
- Excellent research, problem-solving, and communication skills.
- Ability to collaborate with cross-functional teams and external stakeholders to achieve regulatory and quality goals.
The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and qualifications. In addition to a competitive salary, we offer an extended healthcare benefits package, paid vacation time, and personal days.
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