Regulatory Affairs Specialist I

Regulatory Affairs Specialist

Fully remote

About The Company

Joining our team, you’ll play an active part in helping to deliver meaningful impact. At Oxoid Remel Microbiology, acquired from Thermo Fisher Scientific, we play a crucial role in accurate identification and targeted treatment for diseases, ensuring food and beverage safety, and supporting pharmaceutical manufacturing integrity. Our products and services are designed to meet the highest standards of quality and performance, helping our customers achieve their objectives efficiently and effectively.

About The Role

Join our collaborative team as a Regulatory Affairs Specialist I at Oxoid Remel, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.

This is an exciting phase of the company's existence with abundant learning opportunities. We're not looking for someone to simply take a seat and work—we want eager individuals who will actively co-create, improve, and collaborate. We seek people who look beyond their own desk, are open to learning, and contribute as and when needed. We value both individual strengths and team spirit, creating an environment where your unique talents contribute to our collective success.

As a valuable member of our Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. You'll also contribute to regulatory intelligence efforts by monitoring regulatory changes, analyzing trends, and maintaining intelligence databases to keep the organization informed of evolving requirements. You'll collaborate with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.

Requirements

While the requirements below are important, we believe cultural fit and willingness to learn are equally essential to success in this role.

• Bachelor's Degree required, no prior experience required
• Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
• Additional qualifications in Quality Management or Regulatory Affairs advantageous
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Excellent organizational abilities and attention to detail
• Strong analytical and problem-solving capabilities
• Ability to work both independently and collaboratively in a matrix environment
• Experience with regulatory databases and submission systems preferred
• Knowledge of GMP, ISO 13485, and quality management systems

More About Us…

This is an exciting time to join us as we continue to build on more than 100 years of microbiology excellence. With a broad portfolio of instruments, services, and global resources, we’re steadfast in our commitment to helping you succeed. Together, we can cultivate a thriving microbiology culture that supports you today, tomorrow, and for life.

Come and be part of what’s next for our company!