At a Glance
- Tasks: Lead regulatory strategies for innovative diagnostics and ensure timely clinical trials.
- Company: Join a global biotechnology leader at the forefront of medical innovation.
- Benefits: Hybrid work model, competitive salary, and a chance to impact healthcare.
- Other info: Contract role with excellent opportunities for professional growth.
- Why this job: Be part of groundbreaking projects that bring life-saving diagnostics to market.
- Qualifications: 5+ years in pharma/diagnostics with IVD experience and strong project management skills.
The predicted salary is between 63000 - 77000 £ per year.
Cpl Life Sciences is partnering with a global leading biotechnology business at the heart of innovation. This role is sitting at the interface of therapeutics and diagnostics, helping bring biomarker-driven medicines to market through companion diagnostic and IVD regulatory strategy.
The Temporary Manager, Regulatory Affairs IVD will provide project management support for performance studies applications and performance study notifications. This role will partner with clinical study teams, site start-up teams, and performance study sponsors to facilitate on-time clinical trials.
The temporary Manager, Regulatory Affairs IVD will be responsible for planning, coordinating, tracking and driving execution of performance study applications and performance study notifications activities in accordance with EU IVDR.
- Lead operational planning of IVD performance study notifications/applications activities.
- Coordinate cross-functional activities required for performance study notifications/applications milestones, trackers, requests for information, and risk mitigation plans.
- Ensure timely responses to regulatory authority requests for information.
- Facilitate communication between performance study sponsors, clinical study teams and regulatory stakeholders.
- Contribute to continuous improvement focused on submission planning, tracking and operational efficiency.
Bachelor's degree in Life Sciences, Engineering or a related technical field.
~5+ years’ pharmaceutical or diagnostics industry experience, including 1-2 years IVD/Medical Device Regulatory Affairs experience.
Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA) and global registrational processes for medical devices/IVDs.
Experience with companion diagnostic development processes and regulatory filings.
Please note this role is a contract role paying a fixed salary and requires someone to be based in the UK or Ireland. You must be comfortable with hybrid working and be on no more than a 4-week notice period.
Director, Regulatory Affairs - Hybrid in Uxbridge employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work environment in the heart of West London, where innovation thrives. With a strong focus on employee growth and development, the company provides opportunities to engage in cutting-edge projects that directly impact patient care. The hybrid working model promotes a healthy work-life balance, making it an attractive choice for professionals seeking meaningful and rewarding employment in the biotechnology sector.
