Regulatory Affairs Specialist I – CMC / Medical Devices (19-00907) – MA – Cambridge

This position will primarily provide regulatory submission process support for Company’s Global Regulatory Affairs (GRA) Devices team, which has responsibility for diagnostics, medical devices and combination products.  This position will interface with regulatory affairs colleagues' world-wide, as well as global research and industrial affairs functions.  The primary scope of activities for this role will be the development, optimization and implementation of regulatory device processes. 

Major Activities/Key Responsibilities:

GRA Device Portfolio Management
 – Building and maintain a tracking system for the complete GRA Device portfolio  – Liaise with cross-functional portfolio teams to identify programs which require GRA Device support, evaluate stage of program and scope of activities required  – Facilitate resource nomination to support the incoming programs  – Maintain the GRA focal point listing with GRA Device representatives

Submission Templates
 – Optimize Company-specific instructions for medical device submission and health authority interaction templates, building on historical experience from prior submissions
 – Develop/optimize CTD template structure and baseline content specific for the delivery device technologies in the Company portfolio (pen injector, autoinjector, large volume device, syringes) for investigational and registration submissions, building on historical experience from prior submissions
 – Lead cross-functional review of these submission template drafts and actively drive the activities to implement the final templates within the document management systems

Device Submission Publishing and Archival Processes
 – Liaise with Global Regulatory Operations to develop processes to support publishing and archival of medical device submission documents, leveraging prior experience managing these submissions

Process and Procedure Development
 – Learn the roles and responsibilities for GRA devices across the various device types (combination product, diagnostics, digital, consumer health, biosurgery)
 – Perform gap analysis of existing procedures to identify areas where improvements can be made to optimize the procedures to account for the GRA device roles and responsibilities
 – Contribute to the design, optimization and implementation of device-related Company Regulatory processes and procedures
 – Participate in the development and optimization of processes and procedures relevant to submissions, representing the device-specific aspects

Knowledge of relevant medical device regulations (FDA, EU, HC, etc.)
Familiarity with the biopharmaceutical development processes
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Excellent in English language, including technical and regulatory writing skills
Proficient in MS Word, Excel, PowerPoint
Experienced in regulatory submission authoring with a clear understanding of eCTD structure and technical writing standards and approaches
Comfort with electronic document management systems and authoring tools
Excellent organizational and communication (written and verbal) skills.
Demonstrated attention to detail and problem-solving abilities
Demonstrated ability to work successfully on project teams.
Able to work independently to drive results

University science degree, with 2 – 4 years of CMC or medical device regulatory experience
Source: Job Diva – Job Listing

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