Regulatory Affairs Manager - IVDs
Cpl Life Sciences · London, England ·
p strong Job Title: /strong Regulatory Affairs Manager - IVDs /p p strong Job Type: /strong Maternity Cover – 12 Month Contract /p p strong Location: /strong West London, UK – Hybrid/Remote /p p strong Salary: /strong £60,000 - £76,000 /p p br /p p strong u Please note that this is a contract opportunity /u /strong /p p br /p p 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. /p p br /p p 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. /p p br /p p 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. /p p br /p p strong u Essential Functions required for the job: /u /strong /p ul li Lead operational planning of IVD performance study notifications/applications activities. /li li Coordinate cross-functional activities required for performance study notifications/applications milestones, trackers, requests for information, and risk mitigation plans. /li li Ensure timely responses to regulatory authority requests for information. /li li Facilitate communication between performance study sponsors, clinical study teams and regulatory stakeholders. /li li Track country-specific submission requirements and maintain submission status trackers. /li li Contribute to continuous improvement focused on submission planning, tracking and operational efficiency /li /ul p br /p p strong u Job
Requirements
/u /strong /p p br /p p Minimal Requirements /p ul li Bachelors degree in Life Sciences, Engineering or a related technical field /li li 5+ years’ pharmaceutical or diagnostics industry experience, including 1-2 years IVD/Medical Device Regulatory Affairs experience. /li li Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA) /li li Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs /li li Excellent written and verbal communication skills /li /ul p br /p p Preferred
Requirements
/p ul li Advanced degree (Masters and above). /li li Experience with companion diagnostic development processes and regulatory filings /li /ul p br /p p 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. /p p br /p p For more information, please contact lucy.kirkaldy@cpl.com /p