Regulatory Affairs Specialist - San Diego, United States - Top Quality Recruitment (TQR)

Description

Employment Type: Full-time

Available Positions: 1

Location: On-Site

Application 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 preferred
• Minimum 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.

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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