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, request 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

· Bachelors degree in Life Sciences, Engineering or 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 (Masters 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. You must be comfortable with hybrid working and be on no more than a 4-week notice period.