Regulatory Affairs Specialist

About the position

As a Regulatory Affairs Specialist at Terumo Blood and Cell Technologies, you will play a crucial role in ensuring that innovative medical devices and therapies comply with regulatory standards. This position involves navigating complex regulatory landscapes, preparing documentation for submissions, and collaborating with various departments to facilitate product approvals. Your expertise will directly impact the timely delivery of healthcare solutions to patients in need.

Responsibilities

• Research and identify product classification and contents for global regulator submissions.
• Coordinate or lead preparation of documents for internal audits and inspections.
• Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions or notifications as required by geography.
• Lead global regulatory assessment for product or labeling changes and compile feedback from regions.
• Summarize collected information into a regulatory strategy and develop and maintain product technical files.
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies for changes.
• Work with manufacturing, engineering, quality, labeling, clinical affairs, and other functional groups on regulatory compliance issues.
• Apply standard procedures and learned knowledge to develop regulatory solutions of low complexity within established guidelines.
• Act as liaison with Terumo BCT International regulatory personnel and/or distributors to address questions and issues that arise as part of the registration and/or testing process.
• Assist in the assembly and creation of documents for new product submissions to government agencies.
• Prepare 510(k)s and/or international submissions as required and coordinate responses to FDA or international agencies.

Requirements

• Bachelor's degree in physical/biological sciences or engineering preferred, or equivalent education and experience.
• Two years of experience in Regulatory Affairs, Clinical Affairs, Product Development, or Quality Assurance, or in another regulated environment, or an advanced degree with less than one year of experience in Regulatory Affairs or applicable area.
• 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 general knowledge with individual products/geographies.
• Demonstrated ability to update sections of a regulatory submission under supervision.
• Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Demonstrated analytical and creative thinking skills and the ability to solve complex problems.

Nice-to-haves

• Quality Assurance or Regulatory Affairs Certification (RAC) desired.

Benefits

• Wellness program
• Health insurance
• Dental insurance
• Vision insurance
• 401(k) matching
• Life insurance
• Pet insurance