Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
ThermoGenesis Corp., a leading player for automated cellular processing and a company which is developing breakthrough platform technologies for regenerative medicine and immune-oncology is looking for a local candidate to fill it’s Regulatory Affairs Specialist position.
Cross functional Regulatory Affairs compliance support and Quality System.
Responsible for providing support in obtaining new domestic and international registrations and licenses and maintaining registration/license renewals. Monitor renewal schedules in collaboration with authorized representatives, sponsors, and distributors. Responsible for obtaining regulatory inputs for product labeling and coordinating the development and maintenance of the labeling. Assists with coordinating and/or participates with regulatory inspections, quality audits, and completing post inspection/audit actions. Monitors and maintains regulatory process metrics, and participates in regulatory and quality based continuous improvement projects. Provides back-up support for document control.
Essential Job Functions:
Responsible for providing documentation as requested from distributors, sponsors, or authorized representatives to support product registrations or renewals worldwide.
Serves as a member of the Regulatory Affairs team in preparing Master Access Files and pre-market submissions for USA FDA clearance to market and/or approvals.
Participates on project teams to provide regulatory input and support; including gathering of post-market documentation.
Serves as the label development subject matter expert. Mentors users on protocols for label change control (standards for graphical content, branding, layout, material and print validation) collaborates with stakeholders on content and design of labels using in the appropriate label software.
Provide support as necessary for submitting adverse reporting and vigilance documentation to regulatory authorities.
Maintains knowledge of current applicable regulations, standards, guidance documents and best practices.
Updates regulatory process SOPs and maintains records as necessary to support quality system compliance.
Gathers and monitors Regulatory System metrics. Provides reports and escalates adverse trends to management.
Provides back up support to the Document Control function as necessary.
Overall Compliance and Continuous Improvement
Promotes quality system concepts and regulatory requirements.
Identifies opportunities for improvement in the RA and QMS programs.
Leads or participates in non-conformance, corrective action and preventive action investigations and action plan implementation as well as continuous improvement projects as necessary.
Provides support during compliance and quality system audits as required.
Minimum of 5 years previous experience in medical device, or related industry.
Minimum of 2 years previous experience in Regulatory Affairs; domestic and international preferred.
21 CFR 820 System Regulation, Medical Devices; CGMP (US).
93/42/EEC Medical Device Directive (EU) or equivalent.
ISO 13485 Medical Device Quality Management Systems
Medical device labeling standards.
Document/Record Control systems; electronic preferred.
Highly motivated and dedicated to quality principals.
Organized, thorough, and detailed oriented.
Experience in Quality Management System software, Enterprise Resource Planning systems, Microsoft Office suite.
Solution driven, analytical and problem-solving skills.
Excellent prioritization and communication (verbal and written).
Bachelor’s Degree in a related field preferred. Minimum High School diploma with relevant trade school or college level courses in a related field.
Job Type: Full-time
Internal Number: 090519
About Cesca Therapeutics (ThermoGenesis Corp.)
ThermoGenesis Corp., is a leading player for automated cellular processing and a company which is developing breakthrough platform technologies for regenerative medicine and immune-oncology .