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Regulatory Consultant/ Senior Consultant

Middlesex   •  £45,000 - 75,000  •  Permanent, Full time

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
  • Posted: 9th May 2023
  • Expires: 6th June 2023

Cpl Life Sciences

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