Regulatory Affairs Specialist I

Cambridge, MA

Posted: 10/08/2019 Industry: Biotech/R&D/Science Job Number: 49631



This position will primarily provide regulatory submission process support for 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 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 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 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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