Regulatory Affairs Specialist

Responsibilities: As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:

• Gathering and organizing regulatory data to deploy a regulatory information management tool.
• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
• Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
• Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
• Review and approve advertising, promotional items and labeling for regulatory compliance.
• Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities.
• Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project. Additionally, the Regulatory Specialist will: Communicate application progress to internal stakeholders Collaborate with worldwide colleagues regarding license renewals and updates Maintain regulatory files and tracking databases as required Communicate with regulatory agencies as needed Mentor other regulatory affairs personnel within the team. Support the audit team as subject matter expert.

Your Profile:

Bachelors degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry Minimum 3 years of regulatory approvals and submittal experience (US, and rest of world) in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic (preferred) medical device company (FDA class II equivalent-Class III a plus). Must be able to manage multiple tasks and perform with accuracy and a high attention to detail Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision Excellent working knowledge of medical device regulations (21 CFR), FDA law, MDD, MDR, other global laws and regulations. Proficient knowledge of domestic and international standards Recent experience with successful preparation of FDA 510(k) submissions, PMA or international documents or registration and marketing of medical devices worldwide. RAPs RAC strongly preferred Understand LEAN concepts, methodologies and deployment Strong background in design controls. Proficient computer skills in Microsoft Office,4 contingent workers planned for first half of 2025 to finish Rimsys deployments in business units with larger portfolios: US, HPM, and SRC. Start date delayed to January to enable meeting RA head count targets for 2024.