Scientific Affairs & Regulatory Support Specialist (ZR_23849_JOB)
Scientific Affairs & Regulatory Support Specialist (ZR_23849_JOB)
Posted on :
07-06-2025
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1 Vacancy
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Monthly Salary
2123 - 2123
Vacancy
1 Vacancy
Posted on :
07-06-2025
Job Description
This is a remote position.
Schedule:
Client Overview:
Join a pioneering medical diagnostics company that s revolutionizing stroke diagnosis with the world s first blood test for strokes - think of it as the COVID test for strokes. This groundbreaking biotech company founded by Cambridge University experts is at an exciting inflection point having successfully completed all clinical trials and now scaling into full commercialization. With stroke being the second leading cause of death globally and the first cause of disability this company s innovative diagnostic technology will directly impact patient outcomes and save lives worldwide. Based in Cambridge UK this is your opportunity to be part of a team that s transforming emergency medicine and making breakthrough medical innovation accessible globally.
Job Description:
This is an exceptional opportunity to join a cutting-edge medical diagnostics company as they transition from successful clinical trials to full-scale commercialization of life-saving technology. You ll work directly with the Chief Scientific Officer to drive critical scientific and regulatory initiatives across multiple disciplines gaining invaluable experience in clinical operations regulatory compliance quality management and product development. This role offers the unique chance to contribute to breakthrough medical innovation while developing expertise across the entire IVD product lifecycle from clinical studies through regulatory approval to market launch. You ll be at the forefront of medical technology that will revolutionize stroke diagnosis and treatment making a tangible difference in patient outcomes worldwide.
Responsibilities:
- Mondays to Fridays 8:00 am to 5:00 pm (includes 1-hour unpaid lunch break)
- 40 hours per week
- Client time zone: UK Time
Client Overview:
Join a pioneering medical diagnostics company that s revolutionizing stroke diagnosis with the world s first blood test for strokes - think of it as the COVID test for strokes. This groundbreaking biotech company founded by Cambridge University experts is at an exciting inflection point having successfully completed all clinical trials and now scaling into full commercialization. With stroke being the second leading cause of death globally and the first cause of disability this company s innovative diagnostic technology will directly impact patient outcomes and save lives worldwide. Based in Cambridge UK this is your opportunity to be part of a team that s transforming emergency medicine and making breakthrough medical innovation accessible globally.
Job Description:
This is an exceptional opportunity to join a cutting-edge medical diagnostics company as they transition from successful clinical trials to full-scale commercialization of life-saving technology. You ll work directly with the Chief Scientific Officer to drive critical scientific and regulatory initiatives across multiple disciplines gaining invaluable experience in clinical operations regulatory compliance quality management and product development. This role offers the unique chance to contribute to breakthrough medical innovation while developing expertise across the entire IVD product lifecycle from clinical studies through regulatory approval to market launch. You ll be at the forefront of medical technology that will revolutionize stroke diagnosis and treatment making a tangible difference in patient outcomes worldwide.
Responsibilities:
- Scientific Collaboration Leadership: Facilitate and foster relationships with key scientific collaborators for clinical studies expanding the company s research network and capabilities
- Clinical Operations Excellence: Provide comprehensive operational support to clinical sites and orchestrate the execution of clinical studies including strategic communication and document management
- Regulatory Strategy Support: Contribute to the development and review of project proposals clinical protocols and study reports that drive regulatory approval processes
- Verification & Validation Expertise: Assist in designing and planning V&V studies for regulatory compliance including testing different blood sample types sensitivity assays and drug interference studies
- Data Analysis & Presentation: Analyze complex V&V results and present findings professionally to regulatory bodies ensuring compliance with international standards
- Quality Management System: Participate in maintaining and implementing QMS compliant with ISO 13485 supporting internal audits and corrective action processes
- Regulatory Intelligence: Monitor and analyze changes in relevant regulations (IVDR ISO standards) and contribute to updating documentation and strategic plans
- Grant Funding Support: Assist in securing funding through grant applications and proposal development
- Cross-Functional Project Management: Provide project management support across various scientific initiatives ensuring seamless coordination between teams
Requirements
- Advanced Education: PhD in relevant scientific discipline (biotech biomarkers medical diagnostics or cardiovascular preferred) OR MSc with minimum 2 years relevant industry experience
- Technical Expertise: Strong understanding of IVD product development lifecycle and experience with clinical studies
- Regulatory Knowledge: Familiarity with relevant regulations and standards including ISO 13485 and IVDR 2017
- Communication Excellence: Outstanding English communication skills with ability to present complex scientific data to regulatory bodies
- Adaptability: Proven ability to learn and adapt across multiple scientific disciplines with some experience in academia or industry
- Remote Work Ready: Comfortable working in a remote environment with flexible location options (preference for Spain but open to other locations)
- Growth Mindset: Enthusiasm for working in a fast-paced innovative environment during a critical commercialization phase
- Collaborative Spirit: Ability to work effectively with cross-functional teams including laboratory staff regulatory consultants and senior leadership
- Initial Training Period: Willingness to engage in 1-2 months of intensive supervision and training to ensure success in the role
Benefits
Independent Contractor Perks:
- HMO coverage for eligible locations
- Permanent work from home
- Immediate hiring
- Steady freelance job
Please note that since this is a permanent work-from-home position and an Independent Contractor arrangement the candidates must have their own computer and internet connection. They will handle their benefits and taxes. The professional fees are at hourly rates and the rate depends on your performance in the application process.
ZR23849JOB
Advanced Education: PhD in relevant scientific discipline (biotech, biomarkers, medical, diagnostics, or cardiovascular preferred) OR MSc with minimum 2 years relevant industry experience Technical Expertise: Strong understanding of IVD product development lifecycle and experience with clinical studies Regulatory Knowledge: Familiarity with relevant regulations and standards including ISO 13485 and IVDR 2017 Communication Excellence: Outstanding English communication skills with ability to present complex scientific data to regulatory bodies Adaptability: Proven ability to learn and adapt across multiple scientific disciplines with some experience in academia or industry Remote Work Ready: Comfortable working in a remote environment with flexible location options (preference for Spain but open to other locations) Growth Mindset: Enthusiasm for working in a fast-paced, innovative environment during a critical commercialization phase Collaborative Spirit: Ability to work effectively with cross-functional teams including laboratory staff, regulatory consultants, and senior leadership Initial Training Period: Willingness to engage in 1-2 months of intensive supervision and training to ensure success in the role
Employment Type
Full Time
Key Skills
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