Associate Director Regulatory Affairs CMC – MASS
Eagle Research Incorporated - Massachusetts

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Overview:
  • Position focus is on the development and post-approval of medical devices and combination products in sequence with drug delivery.
Responsibilities include:
  • Contribute to the development and implementation of CMC device regulatory strategy; Identify and assess regulatory risks
  • Serve as the regulatory representative on project teams, making key project related decisions for post-marketing and/or development programs
  • Serve as liaison to internal operations groups, development personnel and manufacturing partners
  • Serve as regulatory contact with relevant regulatory authorities, and coordinating device CMC aspects of regulatory submissions
  • Manage the regulatory submission process through to approval, including management and coordination of the preparation of regulatory documentation
  • Provide critical review of regulatory submissions to ensure accuracy, adequacy, consistency and conformance to regulatory requirements and proper language
Requirements include:
  • Regulatory experience for medical devices and combination products
  • Familiarity with Medical Device regulations, Good Manufacturing practices and a record of successful submission strategies for combination products
  • BA/BS/University degree required, Life/Health Sciences preferred.
Additionally, the candidate should have:
  • Demonstrate excellent communication and influencing skills internally and externally
  • Demonstrate effective cross-functional and cross cultural skills, strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
  • Ability to apply analytical and creative thinking problem solving
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Demonstrate strong organizational skills, including the ability to prioritize workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.

Eagle Research Incorporated - 22 months ago - save job