Regulatory Affairs Specialist

At Terumo Blood and Cell Technologies, our 8,000+ global associates come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. As a Regulatory Affairs Specialist , you will play a key role in bringing innovative medical technologies to patients around the world. You will support global product registrations, develop regulatory strategies for product and labeling changes, prepare FDA 510(k) and international submissions, and collaborate cross‑functionally with engineering, quality, manufacturing, clinical, and labeling teams to ensure compliance across worldwide markets. ESSENTIAL DUTIES Research and identify product classification and contents for global regulatory 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, compile feedback from regions, and summarize collected information into a regulatory strategy. 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; may collaborate with individuals at different levels in solving routine problems and interpret, execute, and recommend modifications to operating policies where appropriate. 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. Provide regulatory support to internal customers that may be critical to short‑term and intermediate objectives of the department. Assist in the assembly and creation of documents for new product submissions to government agencies. Maintain moderately complex licenses/certificates, product approvals, and post‑market notifications. Prepare 510(k)s and/or international submissions as required. Coordinate responses to FDA or international agencies. Recommend strategies for earliest possible approvals/clearances for new product introductions in the US, Canada and EU. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Two (2) years experience preferred in Regulatory Affairs, Clinical Affairs, Product Development or Quality Assurance or another regulated environment. Or an advanced degree with 0 years of experience in Regulatory Affairs or applicable technical degree. Skills Knowledge of U.S. and/or international medical device, 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. Must be highly skilled in timely and accurate decision‑making; demonstrated analytical and creative thinking skills and the ability to solve complex problems. Able to identify adequacy of submission sections and overall content of submissions. Able to identify gaps and suggest solutions. Must be self‑motivated by working independently and have the ability to take ownership of responsibilities. Certificates, Licenses, Registrations Quality Assurance or Regulatory Affairs Certification (RAC) desired. LOCATION Lakewood, Colorado or Remote PHYSICAL REQUIREMENTS 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. Target Pay Range Salary range: $80,200.00 to $100,300.00. Target bonus on base: 7.0%. Benefits We provide competitive total reward offerings that consist of compensation, benefits, recognition, and a wealth of other well‑being and work‑life programs. Included benefits are group medical, dental, and vision plans; a robust wellness program; life insurance and disability coverage; voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance; and a 401(k) plan with a matching contribution. Vacation and sick time programs help balance work and life. Equal Employment Opportunity We are proud to be an Equal Opportunity, affirmative action employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, status under a protection order, national origin or ancestry, citizenship status, age, unrelated disability, military status or an unfavorable discharge from military service. We are committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco‑free. We maintain a drug‑free workplace and perform pre‑employment substance abuse testing and detailed background verification. #J-18808-Ljbffr