Quality Systems & Regulatory Affairs Specialist

RESPONSIBILITIES:

• Interprets international regulatory and quality requirements for medical devices. 
• Creates detailed regulatory and quality deliverables for international distribution of medical devices in countries such as Canada, Japan, EU, Brazil, etc.
• Prepares regulatory submissions for medical devices and maintains regulatory clearance through the product lifecycle.
• Interfaces with internal stakeholders such as engineering, product, and clinical to ensure regulatory and quality considerations are communicated throughout the product development lifecycle. 
• Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements.
• Supports maintenance of the quality management system. 
• Supports regulatory assessments of post-market changes and reportable events.
• Supports and leads internal and external audit activities to maintain QMS certifications.

QUALIFICATIONS:

• Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience.
• At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea.
• Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision.
• Demonstrated history in achieving regulatory market authorization. 
• Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy. Experience with AI/ML is a plus.
• Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc).
• Passion for delivering impactful and high-quality products to people.