Regulatory Affairs Specialist

Employment Type: Full-time Available Positions: 1 Location: On-SiteApplication Deadline: May 2nd, 2024 Summary The Principal Regulatory Affairs Specialist will be responsible for a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance Key Activities Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, and Agency/industry initiatives, especially around SW including AI and ML, etc. to ensure a regulatory strategy is in alignment with company objectives and ensure standard and process compliance.Responsible for developing and implementing global regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy.Responsible for product registration submissions/approvals for the US, Canada, EU, and selected worldwide locations. Review and approve advertising, promotional items, and labeling for regulatory compliance.Identify potential regulatory approval risks based on changes in regulations, standards, country-specific issues, or other unique characteristics of the project.Lead a team within a Regulatory or Cross Functional Team to set and deliver the objectives. Mentor other regulatory affairs personnel within IGTD Regulatory.Communicate application progress to internal stakeholders and with regulatory agencies as needed.Provide audit, CAPA, and post-market regulatory support. Maintain regulatory files and tracking databases as required.Reporting to the Director of Regulatory Affairs- Coronary Vascular you will collaborate with worldwide colleagues regarding license renewals/updates and advise sustaining and NPD/product design teams on regulatory strategy and requirements for new products/solutions.This Hybrid-based role may require travel up to 10% (some international).

Preferred Skills Microsoft Office, able to manage multiple tasks, perform with accuracy/high attention to detail and understand LEAN concepts, methodologies, and deployment. Educations & Experience

Bachelor’s Degree, preferably in Regulatory Affairs and/or a science-related field (Required). Master’s degree desired. RAPs RAC strongly preferredMinimum of 10 years of Regulatory Affairs experience within FDA-regulated medical device/technology environments, including regulatory approvals, submittals-FDA 510K, PMA, IDE, EU MDD/MDR, Health Canada, Technical Files/Design Dossiers, SaMD, and familiarity with Artificial Intelligence/Machine Learning Are you looking for your next opportunity? We can help. Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible. TQR is an equal opportunity employer that encourages diversity. We will consider all applications. Accommodation for applicants with disabilities is available upon request. Are you looking to hire? Get started here:https://www.topqualityrecruitment.com/fill-a-position/ See hiring advice: https://www.topqualityrecruitment.com/blog/ See all available opportunities: https://www.topqualityrecruitment.com/jobs/ We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application. Job ID: 7215