Regulatory Affairs Manager - IVDs

Job Title: Regulatory Affairs Manager - IVDs

Job Type: Maternity Cover – 12 Month Contract

Location: West London, UK – Hybrid/Remote

Salary: £60,000 - £76,000

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

***Please note that this is a contract opportunity***

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.

Essential Functions required for the job:

• 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.
• Track country-specific submission requirements and maintain submission status trackers.
• Contribute to continuous improvement focused on submission planning, tracking and operational efficiency

Job Requirements:

Minimal Requirements

• 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)
• Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs
• Excellent written and verbal communication skills

Preferred Requirements:

• Advanced degree (Master's and above).
• 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. xwzovoh You must be comfortable with hybrid working and be on no more than a 4-week notice period.

For more information, please contact