Regulatory Affairs Specialist

Regulatory Affairs Specialist Date: Jul 17, 2026 Location: Lakewood, CO, US As a Regulatory Affairs Specialist, you'll play a key role in bringing innovative medical technologies to patients around the world. In this position, you'll 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

Reserach, and identifiy product classification and contents for global regulatory submissions. Coordinates or leads 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. Leads global regulatory assessment for product or labeling changes. Compiles feedback from regions. 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. Works with manufacturing, engineering, quality, labeling, clinical affairs and other functional groups on Regulatory compliance issues. Applies standard procedures and learned knowledge to develop regulatory solutions of 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. Acts 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. Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department. Assists in the assembly and creation of these documents for new product submissions to government agencies. Maintenance of moderately complex licenses/certificates, product approvals, and post market notifications. Prepares 510(k)s and/or international submissions as required. Coordinates responses to FDA or international agencies. Recommends strategies for earliest possible approvals/clearances for new product introductions in the US, Canada and E U.

MINIMUM QUALIFICATION REQUIREMENTS

Education 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. 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 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. Demonstarted 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 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. 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 having the ability to take ownership of her/his responsibilities. Certificates, Licenses, Registrations Quality Assurance or Regulatory Affairs Certification (RAC) desired.

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: $80,200.00 to $100,300.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 7.0% We are proud to be an Equal Opportunity Affiliated 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, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Nearest Major Market: Denver Job Segment: Medical Device, Product Development, Quality Assurance, Testing, Behavioral Health, Healthcare, Research, Technology #J-18808-Ljbffr TERUMO BCT, INC