Regulatory Affairs Specialist

What You Will Do

• Serve as the Management Representative with the responsibility and authority, maintain an effective Quality Management System (QMS), and report to top management on its effectiveness at planned management review meetings.
• Responsible for the preparation and documentation of regulatory submissions to government agencies.
• Gather information from technical and project personnel that addresses the performance of the Company's software products and medical devices.
• Ensure adequate documentation exists for software products and medical device claims and directs timely review of regulatory documents.
• Create, review, and update regulatory SOPs as needed.
• Support process improvement for regulatory affairs and quality assurance functions.
• Provide regulatory and quality assurance advice for ongoing and new projects.
• Lead product risk evaluation and management activities.
• Initiate Corrective Action Reports to management and resolution.
• Monitors FDA, MDD / MDR, HSA, and key target markets' agency laws and regulations, and provides recommendations and assistance to ensure company compliance.
• Prepare technical dossier for submission to regulatory authorities in key target markets.
• Direct certification application activities, including sending and tracking certification letters.
• Brings regulatory affairs and quality assurance questions / issues to the attention of management.
• Prepare responses to the agency's questions with good writing and communication skills.

What You Will Need To Have

What Makes You Awesome Working With Us