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(Senior) Regulatory Affairs Consultant - CMC Medical Devices - based EU/UK

Parexel International Corporation

United Kingdom, Remote

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 CMC / 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 CMC / 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 CMC /device documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines.

Ensures effective communication of CMC / 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 CMC / device risk analysis (or regulatory Risk Capture Document) and supports associated RA CMC / device challenge sessions.

Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC / device questions raised in regions assigned for assigned projects/products.

Provides regulatory affairs CMC / device input for assigned projects/products.

Functions as regulatory CMC / device regional representative for assigned projects/products.

Provides regulatory assessments for CMC / 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

At least five years specific regulatory CMC / Device experience

Proven track record of successful authoring and contribution to delivering GRA-CMC module 3 sections of marketing authorizations and IMPD/IND

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)

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Job posted: 2023-02-02

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