Highlights
- Location Basingstoke, Hampshire
- Start Date Immediately
- Work Location Allows Remote Work
Skills
- Fda Regulations
- Iso 13485 Knowledge
- Regulatory Intelligence
- Submission Systems
- Technical Documentation
- Medical Device Regulations
- Quality Management Systems
- International Regulatory Requirements
- Compliance Documentation
- Technical Writing
- Regulatory Submissions
- Regulatory Affairs
- Documentation Management
Fully remote
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
