Regulatory Affairs Specialist

Terumo BCT, Inc. • Denver, CO

21h • $80,200 - $100,300 • Hybrid

About The Position

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. This is an excellent opportunity for a Regulatory Affairs professional with experience in medical devices, pharmaceuticals, biologics, quality, or product development who is looking to expand their global regulatory expertise, influence new product introductions, and contribute directly to the successful commercialization of healthcare products.

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.
• 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.
• 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 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 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.

Nice To Haves

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

Responsibilities

• 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. 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 problems that are routine in nature. 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.
• Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department.
• Assist 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.
• 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.

Benefits

• Multiple group medical, dental and vision plans
• Robust wellness program
• Life insurance
• Disability coverages
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
• 401(k) plan with a matching contribution
• Vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level