We are looking for a Sr. RA Specialist.
The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide labeling and change control coordination for Administration and Safety System medical devices. Responsible for leading projects in support of product labeling activities throughout various stages of design and development of delivery systems and combination products. Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to Wests products and services.
Essential Duties and Responsibilities:
Accountable for initial creation and control process for labeling of administration and safety systems in the form of development and maintenance of labeling proofs, associated labeling documents, maintain labeling issuance and tracking systems, and provide status updates to management change requests and notification to stakeholders, ensuring documents are produced in a timely manner in accordance with West procedures and regulatory requirements.
Manage change controls, receiving input from Regulatory SMEs on impact in regions product is registered.
Apply comprehensive strategic and knowledge, skills/abilities and understanding of the regulatory frameworks, regulatory requirements.
Accountable for strategic and tactical guidance to product labeling review teams regarding development and maintenance of labeling and associated documents.
Determine translations requirements to develop and maintain a translation process required for global labeling.
Other duties as assigned.