At a Glance
- Tasks: Manage regulatory affairs for innovative diagnostics and support clinical trials.
- Company: Join a leading biotechnology firm at the forefront of medical innovation.
- Benefits: Remote work flexibility, competitive salary, and a chance to make a real impact.
- 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: Bachelor's in Life Sciences or Engineering with 5+ years in regulatory affairs.
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.
Qualifications:
- 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.
Regulatory Affairs Manager - Remote in Uxbridge employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the biotechnology sector. With a strong focus on employee growth and development, team members benefit from hybrid working arrangements in West London, allowing for a balanced work-life integration while contributing to groundbreaking projects in regulatory affairs. The company values continuous improvement and provides opportunities for meaningful contributions to the advancement of healthcare solutions.
