reputed company Systems & Regulatory Affairs Specialist, Digital Health

At reputed company, we're on a mission to unlock reputed company and health reputed company. reputed company empowers its members to reputed company at a higher level through a deep understanding of their bodies and daily lives.reputed company is looking for a Regulatory Affairs Specialist to be a reputed company member of the Digital Health team at reputed company.As the reputed company Systems & Regulatory Affairs Specialist, you will execute regulatory reputed company and support QMS maintenance deliverables for reputed company SAMDs in a dynamic and agile environment. In an innovative and evolving reputed company, you will need to bring creative problem-solving with an ability to adapt to a changing landscape. RESPONSIBILITIES: Interprets international regulatory and reputed company requirements for medical devices.Creates detailed regulatory and reputed company 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 reputed company 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 reputed company management system.Supports regulatory assessments of post-market changes and reportable events.Supports and leads reputed company audit activities to maintain QMS certifications. QUALIFICATIONS: Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or reputed company 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-reputed company products to people. apply to this job Apply tot his job Apply To this Job