(Senior) Regulatory Affairs Consultant – CMC Medical Devices – based EU/UK @ Parexel

We are looking for Regulatory Affairs Professionals on various levels (Senior Associate, Consultant or Senior Consultant) for a client dedicated project within Parexel FSP Group who have experience with CMC Medical Devices. This role can be home or office based in multiple locations in Europe.

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.
• Functions as regulatory device regional representative 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
• Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
• 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 (inhalation devices, syringes, auto injectors)