CT19

www.ct-19.co.uk

3 Jobs

10 Employees

About the Company

We aim to positively impact people's lives by connecting talent with opportunity through a well-managed, ethical recruitment process.

Initially working within biotechnology and medical technology, we are now partnering with 'Tech For Good' companies across The UK, EU & US.

Listed Jobs

Company Name: CT19
Job Title: Senior Software Engineer
Job Description: **Job Title:** Senior Software Engineer **Role Summary:** Develop secure, compliant Python-based software for medical devices and surgical robotics. Ensure quality through validation, verification, and regulatory compliance. **Expectations:** - Master’s degree in Computer Science, Engineering, or related field. - 5+ years in medical device/safety-critical software development (Python focus). - Proven experience with FDA/EU medical device regulatory compliance. **Key Responsibilities:** - Design, develop, and maintain medical device software in Python. - Implement secure deployment systems (licensing, authentication, compliance monitoring). - Develop automated testing, validation, and verification frameworks for ISO 13485, IEC 62304, FDA compliance. - Validate cybersecurity and data integrity controls (HIPAA/GDPR). **Required Skills:** - Python programming for medical devices. - Software validation/verification (V&V), QA, and regulatory compliance. - Secure deployment, CI/CD pipelines, automated testing, cybersecurity best practices. **Required Education & Certifications:** - Master’s degree in Computer Science, Engineering, or equivalent. - Familiarity with medical device regulations (FDA, IEC 62304) and cybersecurity standards.

Company Name: CT19
Job Title: Project Manager
Job Description: **Job Title**: Project Manager **Role Summary**: Lead cross‑functional, customer‑focused technical projects in a sustainability startup, coordinating R&D, engineering, and external partners to deliver first‑of‑a‑kind textile recycling solutions. **Expectations**: - Act as the primary liaison between internal teams (R&D, Engineering, Leadership) and external stakeholders (customers, manufacturers, development partners). - Manage end‑to‑end project lifecycle: planning, execution, monitoring, and delivery of milestones for high‑impact clients. - Provide clear, timely communication and actionable insights to support strategic decisions. **Key Responsibilities**: 1. Drive customer projects with global brands across fashion, sports, and automotive sectors. 2. Coordinate production with external partners to meet customer specifications and support engineering validation at the FOAK recycling facility. 3. Facilitate cross‑functional collaboration, ensuring alignment of priorities and resources. 4. Develop and maintain detailed project plans, agendas, and progress reports. 5. Establish efficient communication systems and share results to generate actionable insights. 6. Champion the company’s sustainability mission and collaborative culture. **Required Skills**: - Proven experience (5+ years) in project management or program coordination. - Strong stakeholder management and negotiation skills. - Fluent in French and English; excellent written and verbal communication. - Highly organized, detail‑oriented, and solution‑driven. - Comfortable working under ambiguity and setting independent priorities. - Experience in early‑stage or technology commercialization environments. - Familiarity with project management tools (e.g., MS Project, JIRA, Asana). - Optional: PMP, Prince2, or equivalent project‑management certification. **Required Education & Certifications**: - Bachelor’s degree in Polymer, Chemical, Mechanical, or Environmental Engineering, or Chemistry. - Preference for additional certification such as PMP or Project Management Professional.

Company Name: CT19
Job Title: Director of Regulatory Affairs
Job Description: **Job Title** Director of Regulatory Affairs – EU **Role Summary** Lead EU regulatory strategy and MAA filings for rare disease biologics, spanning early and late‑phase development through commercialization. Own lifecycle management, ensuring regulatory compliance and enabling successful product launches. **Expectations** - Deliver high‑quality MAAs to EMA (and MHRA, Swiss Medic) for new indications. - Provide strategic regulatory guidance on orphan and first‑in‑class programs. - Operate in a fast‑paced biotech environment, adapting to pipeline changes. **Key Responsibilities** - Develop regulatory strategy for preclinical to commercial phases across multiple indications. - Prepare and submit MAAs, including technical, clinical, and quality dossiers, to EMA, MHRA, and Swiss Medic. - Coordinate cross‑functional teams (clinical, QC, commercial, IP) to meet regulatory milestones. - Monitor EU regulatory developments and assess their impact on the pipeline. - Advise on orphan drug designation, best‑in‑class status, and lifecycle management. - Liaise with EU authorities, facilitate inspections and consultations. - Support launch and post‑marketing activities through regulatory oversight. **Required Skills** - In‑depth knowledge of EMA, MHRA, Swiss Medic pathways; orphan drug and first‑in‑class experience. - Proven MAA submission and lifecycle management experience. - Strategic thinking with hands‑on execution capability. - Strong communication, stakeholder management, and cross‑functional collaboration. - Analytical problem‑solving skills. - Adaptability to a dynamic, demand‑driven biotech setting. **Required Education & Certifications** - Bachelor’s or Master’s in Life Sciences, Pharmacy, Biomedical Sciences, or Regulatory Affairs. - Professional certification in Regulatory Affairs (e.g., RAPS, RA) preferred. ---

Belgium

Remote

28-11-2025