Regulatory Affairs Principal Specialist
2 weeks ago
Position Overview
At Terumo Blood and Cell Technologies, we are dedicated to improving patient outcomes through innovative medical devices and solutions. Our global team of over 7,000 associates is committed to making a difference in the lives of patients worldwide.
Role Summary
We are seeking a highly experienced Principal Regulatory Affairs Specialist to spearhead our submissions processes for FDA, Health Canada, and EU MDR. In this pivotal role, you will utilize your extensive knowledge to navigate complex regulatory frameworks, ensuring that our cutting-edge healthcare products receive the necessary approvals.
Key Responsibilities
- Develop and implement comprehensive regulatory strategies.
- Collaborate with cross-functional teams to ensure compliance with global regulations.
- Manage the complete lifecycle of multiple complex products and projects.
- Serve as a liaison with regulatory agencies, fostering positive relationships throughout the development process.
- Analyze and recommend modifications to operating policies that align with business objectives.
- Provide mentorship and technical guidance to regulatory associates and cross-functional teams.
Qualifications
- Bachelor's degree in physical/biological sciences or engineering; advanced degrees such as a Master's in Regulatory Affairs or MBA are preferred.
- A minimum of 10 years of experience in Regulatory Affairs, with a strong background in clinical or statistical environments.
- Proven track record in managing regulatory submissions for medical devices, including CE Mark, IDEs, INDs, 510(k)s, NDAs, and ANDAs.
- Expertise in relevant regulations such as CFR 820, ISO 13485, and ISO 62304.
Skills and Attributes
- Strong analytical and creative problem-solving skills.
- Excellent communication abilities, both verbal and written.
- Demonstrated capacity to work collaboratively across various functions and influence decision-making processes.
- Proficient in relevant software applications.
Work Environment
This position can be performed remotely or at our Colorado location. Some travel may be required.
Compensation and Benefits
We offer a competitive salary range, along with a comprehensive benefits package that includes medical, dental, and vision plans, retirement savings options, and wellness programs.
Join us at Terumo Blood and Cell Technologies, where your expertise will contribute to advancing healthcare solutions that impact lives every day.
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