Regulatory Affairs II

ID# DCFL27716

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Provides support for Worldwide Regulatory initiatives by: 

  • Supporting Regulatory Colleagues, Project Teams, and Clinical Affairs by researching, assessing, and documenting the Regulatory Requirements and Strategies for medical device submissions and clinical studies worldwide
  • Assistance in the development and maintenance of a Regulatory/Clinical Requirements knowledge database
  • Supporting the development and assessment of product/clinical labeling including, but not limited to, primary and secondary packaging, and instructions for use documents 
  • Supporting other Regulatory initiatives, such as those related to product labeling, as required 

Masters Complexity 

  • Works independently on routine tasks while requiring some supervision on non-routine and/or complex issues
  • Technical expert for job function
  • Conceptual understanding of all responsible functions and business areas. 

Innovation

  • Prioritizes work to meet deadlines. 
  • Suggests and implements tactical direction for functional area. 
  • Researches and benchmarks creative solutions. 

Customer Focus 

  • Meets customer service requirements by developing the basic work assignments and tactical plans to get the work done, and/or, contributes expertise to programs and projects. 

Interdependent Partnering

  • Works skillfully in cross functional teams to complete task at hand while ensuring compliance. 
  • Utilizes effective mediation/conflict management, negotiation, and internal/external influencing skills. 
  • Identifies and resolves relationship issues. 

Organizational & People Development

  • Responsible for individual development. 
  • Influences day-to-day harmony within the group. 
  • Recommends and supports technical and process improvements. 

 

ESSENTIAL FUNCTIONS / RESPONSIBILITIES 

  1. Research, assessment, and documentation of worldwide medical device submissions and clinical study requirements and strategies (30%) 
  2. Development and maintenance of Regulatory/Clinical requirements knowledge database (25%) 
  3. Development and assessment of product/clinical labeling (primary, secondary, instructions for use) (25%) 
  4. Miscellaneous Regulatory labeling project support including, but not limited to, approved product labeling review, instructions for use review and maintenance, historical labeling records maintenance and research (20%) 

QUALIFICATIONS 

Minimum education required for competent performance: 

  • Bachelors Degree (or equivalent) 

Minimum experience required for competent performance: 

  • 2 years of working experience within the Pharmaceutical or Medical Device Regulatory environment. 
  • Previous experience with clinical trials and international Regulatory requirements is preferred. 
  • Excellent project management skills working with a cross-functional team is required. 
  • Strong communication, organizational, negotiation and interpersonal skills.
  •  Keen attention to detail is essential. 
  • General knowledge, understanding and application of principles, concepts and practices of government regulations. 
  • Broad based technical knowledge in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.). 
  • Ability to organize and analyze data and suggest issues or gaps. 

Position Details:

Medical Device

Clinical Research

Start Date: 
11-4-2013
End Date: 
11-1-2014

JACKSONVILLE, FL

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DCFL27716

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