Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals, or biologics.
Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas
Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
Maintenance of sometimes complex existing licenses/certificates, product approvals and simple post market notifications
Responsible for overall compliance with Regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve compliance.
Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues
Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems that are routine in nature. Interprets, executes, and recommends modifications to operating policies where appropriate
The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department
Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 4 years experience in Regulatory Affairs.
Certificates, Licenses, Registrations
Quality Assurance or Regulatory Affairs Certification (RAC) desired
In depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
Familiarity with regulatory standards and demonstrates general knowledge with individual products/geographies
Demonstrated ability to author sections of a regulatory submission under supervision, with content review at end
Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
Recognize and awareness of gaps and potentially suggest solutions. Able to identify adequacy of sections and overall content of submissions
Knowledge and use of relevant PC software applications and skills to use them effectively
Demonstrated ability to communicate effectively both verbally and and in writing
Must be highly skilled in timely and accurate decisions Demonstrated analytical and creative thinking skills and the ability to solve complex problems
Terumo BCT is a global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. Terumo BCT believes in the potential of blood to do even more for patients than it does today.