Senior Regulatory Affairs Specialist

Position:

Sr. Regulatory Affairs Specialist

About You:

The Sr. Regulatory Affairs Specialist will be working with multiple business units to develop, update and improve regulatory affair processes. You'll also assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

About the Company:

Our client is a global leader in collagen-based biomaterials development and supply for use in regenerative medicine, medical devices, diagnostics, and research. Their culture of responsiveness and customer engagement reflects their global team's talent and passion for biomaterials science, production and overall service. They look for high-caliber team members passionate about their vision to become the industry's first choice for regenerative biomaterials.

Responsibilities:

• Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including ISO 13485, FDA, QSR, EU MDR, EDMQ
• Identify opportunity for regulatory affair processes and drive changes to completion
• Assist VP Quality and Regulatory Affairs and answer issues with government regulatory personnel
• Serve as a member of the Global Regulatory Affairs department and will have direct reporting to the VP of Quality & RA
• Function as a direct link between the global and local RA team members to ensure local and regional regulatory reporting plans are understood between the regions
• Provide guidance and strategy for U.S. regulatory submissions by providing documentation and by providing requirements for U.S. submissions to the product development teams
• Work with cross-functional teams in drafting and review of customer notifications
• Review on market product changes for regulatory report ability and advise the product development team on types of changes that require regulatory submission prior to marketing/commercialization
• Participate in process improvement projects
• Support process owners and global product manufacturing sites to address internal/external audit and inspection findings for adverse event and recall/ product corrective actions
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Provide regulatory support and guidance for the development of new products, including support of acquisitions, from a regulatory perspective
• Product registration, including 510k and CE Marking, new product development regulatory compliance and participation on new product project team.
• Facilitate communication of information among governance committees and serve as liaison on accreditation issues and changing standards
• Oversea, train and mentor new and existing employees in regulatory and other departments.
• Represent regulatory affairs during audits by agencies
• Manage UDI database
• Review client submitted labels/labeling for compliance to stated and supported claims.
• Provide contract or clients appropriate and relevant information for gaining their regulatory approvals and registrations
• Contribute to implementation of new requirements and compliance with the quality management system
• Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and benchmarking state-of-the-art practices

Education & Experience:

• Bachelor's degree
• 5+ years' relevant experience

?? Computer literacy and strong skills with Office 365

?? Practical experience in manufacturing or science

Knowledge & Skills:

• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and knowledge ISO 14971.
• Excellent verbal and written communication skills and strong attention to detail
• Must be highly organized with the ability to manage and prioritize multiple projects/tasks