Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle, including pre-clinical, clinical, regulatory approval, and postapproval phases. Navigate key Regulations and Guidance Documents including MDR Regulation (EU) 2017/745, UK MDR, FDA CFR 21, and guidances such as NBOG, MDCG, and FDA Deciding When to Submit a 510(k) in order to assess the Regulatory impact of product modifications, new product development projects, Issue Impact Assessments, and Supplier Change Requests, for the Core Suture portfolio. Analyze and monitor global and local regulations and standards applicable to medical products, ensuring compliance with regulatory requirements from agencies while identifying risks and opportunities. Support Manufacturing Site Inspections and Audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions. Support Globalization of Core Suture Portfolio including development and execution of regulatory strategies to support product registration and market access in US and international markets including Egypt, LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. Position works a hybrid model, requiring the employee to be onsite in North Haven, CT 3-4 days per week.