Regulatory Affairs Consultant / Senior Consultant CMC – Medical Devices
Remote in UK or EU
£45,000 - £75,000 plus package
Working with one of the world’s most established Pharma's, this role will play a pivotal role and you will be responsible for supporting the CMC regulatory activities relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations).
Main Responsibilities:
· Responsible for developing and implementing the medical device regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
· Identifies supporting documents required for (global) submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
· Ensures that the regional device regulatory strategy for the assigned projects/products are consistent with goals and objectives and meets HA requirements in assigned regions.
· Responsible for writing regional and global device documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines.
· Ensures effective communication of device regulatory strategy, risks, and overall plan for assigned products.
· Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner.
· Prepares or contribute to the preparation of the device risk analysis (or regulatory Risk Capture Document) and supports associated RA device challenge sessions.
· Leads or provides support to cross-functional teams responsible for the preparation of responses to HA device questions raised in regions assigned for assigned projects/products.
· Provides regulatory affairs device input for assigned projects/products.
· Provides regulatory assessments for device changes and creation of entries and updates in systems for assigned regions within defined timelines.
Skills and Experience required for the role:
· University degree in a scientific discipline
· At least five years specific regulatory medical device experience
· Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
· Experience of participating in regulatory agency meetings on CMC & Devices matters – preferred.
· Specific requirements: IVD, SaMD and/or combination products: Knowledge in IVD testing or CDx development; Familiarity of IVD, MDR, 510(k) and IMDRF requirements; SaMD; Knowledge in Software as a Medical Device development; Familiarity with digital sensors, RTTE, data privacy and cybersecurity requirements; Combination products.
To be considered please respond with an updated version of your CV and I will be in touch to discuss this further – lucy.kirkaldy@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2305-515614
Website: Cpl Life Sciences
- Posted: 9th May 2023
- Expires: 6th June 2023
