6 senior regulatory affairs specialist jobs found

Senior Regulatory Affairs Specialist (IVDR / CDx Performance Studies) Location: Warrington/UK-based (Remote or Hybrid) Contract: 12 months Hours: 37.5 per week, Monday-Friday (flexible) Start date: ASAP Rate: £80 per hour This is an excellent opportunity for an experienced regulatory professional to take the lead on high‑impact EU Member State notification activities for performance studies relating to Companion Diagnostics under the IVDR. You will play a key role in shaping regulatory strategies, driving timely submission packages, and ensuring the successful execution of complex regulatory interactions across Europe. About the Role In this senior position, you will oversee the preparation, coordination, and delivery of regulatory submissions for IVDR CDx performance studies involving leftover samples. You will act as the primary point of contact for EU Competent Authorities and Ethics Committees, ensuring compliance with regulatory frameworks while supporting strategic...

Senior Regulatory Affairs Specialist Location: Warrington (Remote/Hybrid) Rate: £80 per hour Working Hours: Monday -Friday, flexible between 09:00-18:00 We are seeking a Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. In this role, you will lead and support EU Member State notification activities for IVDR CDx performance studies using leftover samples. You will play a key role in ensuring regulatory compliance while supporting business growth and maintaining competitive advantage across the CDx portfolio. Key Responsibilities Lead EU Member State notification activities for IVDR CDx performance studies Prepare, review, and submit regulatory documentation to Competent Authorities and Ethics Committees Act as the primary contact for regulatory authorities and respond to queries Collaborate cross-functionally (Clinical, Medical, Legal, Quality, Project Management) Maintain accurate regulatory documentation and records...

Senior Regulatory Affairs Specialist Location: Warrington (Remote/Hybrid) Rate: £50-£60 per hour Working Hours: Mon-Fri, flexible between 09:00-18:00 We are looking for an experienced Senior Regulatory Affairs Specialist to join the Life Sciences Group (LSG) EMEA Regulatory Affairs team. This role will focus on managing and leading IVD and Medical Device registrations across EMEA, ensuring compliance while supporting business growth and market expansion. You will work in a highly collaborative, international environment, partnering across functions to deliver effective regulatory strategies and maintain competitive advantage. Key Responsibilities Lead and manage national product and establishment registrations across EMEA Develop and execute regional regulatory strategies aligned with global objectives Act as key contact for regulatory authorities and distributors Oversee submission activities, track progress, and ensure timely approvals Maintain regulatory databases and...

Senior Regulatory Affairs Specialist (IVDR / CDx Performance Studies) Location: Warrington/UK-based (Remote or Hybrid) Contract: 12 months Hours: 37.5 per week, Monday-Friday (flexible) Start date: ASAP Rate: £80 per hour This is an excellent opportunity for an experienced regulatory professional to take the lead on high‑impact EU Member State notification activities for performance studies relating to Companion Diagnostics under the IVDR. You will play a key role in shaping regulatory strategies, driving timely submission packages, and ensuring the successful execution of complex regulatory interactions across Europe. About the Role In this senior position, you will oversee the preparation, coordination, and delivery of regulatory submissions for IVDR CDx performance studies involving leftover samples. You will act as the primary point of contact for EU Competent Authorities and Ethics Committees, ensuring compliance with regulatory frameworks while supporting strategic...

Senior Regulatory Affairs Specialist (EMEA) Location: Warrington (Remote or Hybrid options available) Duration: 12-Month Contract Pay Rate: £50.00 - £60.00 per hour Work Pattern: Monday - Friday, 37.5 hours per week (Flexible hours between 09:00 and 18:00) The Role We are seeking a high-energy Senior Regulatory Affairs Specialist to provide leadership and strategic support for IVD/MD (In Vitro Diagnostic and Medical Device) registrations across the EMEA region. Reporting to the Director of Regulatory Affairs EMEA, you will work within a dynamic, international environment to ensure market growth and revenue protection through strict regulatory compliance. This is a versatile role that can be performed remotely or as a hybrid arrangement out of our Warrington site, with occasional business travel (approx. 10-15%) for escalations and site visits. Key Responsibilities Registration Leadership: Lead national product and establishment registrations across EMEA markets, ensuring all...

Sr. Regulatory Affairs Specialist Are you a proactive regulatory professional looking to lead critical compliance activities in the life sciences sector? We are seeking a Sr. Regulatory Affairs Specialist to join a dynamic international team for a 12-month contract. This role offers the flexibility of remote or hybrid working and is based out of Warrington. The Role In this leadership-focused position, you will provide hands-on support for EU Member State notifications concerning IVDR CDx performance studies. You will be responsible for developing regulatory application strategies that align with business objectives, ensuring timely submissions and maintaining full regulatory compliance across the EMEA region. Your Responsibilities Notification Management: Lead and manage notification activities for IVDR CDx performance studies involving leftover samples. Documentation & Submission: Prepare, review, and submit notification packages to EU Competent Authorities and Ethics...