RA Specialist - Round Lake, IL
Previous Job
Previous
RA Specialist - Round Lake, IL
Ref No.: 18-18175
Location: Lucknow, Maharashtra
Position Type:Contract
Start Date: 03/19/2018
RA Specialist - Round Lake, IL
Mandatory Domain:
Medical Domain with Regulatory Affairs Background
Skills: RA Specialist, Medical Products Labeling, UDI, GUDID
 
Drive global regulatory strategy regarding the device product label(s) and labeling (including advertising and promotion) to sustainably support the global registration and ongoing compliance throughout the life cycle of medical device product(s).
In collaboration with cross functional teams, will be responsible for driving global device labeling initiatives into strategic business and project objectives.
  • Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies.
  • Drive regulatory promotional strategies for the review, approval, and submission (as needed) of advertising and promotional materials across products and product types.  Evaluate technical and scientific information in support of product claims.
  • Formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams.
  • Represent or lead the RA labeling function on assigned cross-functional project teams and projects.   Represent client in relevant external industry workgroups, as needed.  Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
  • Monitor applicable global regulatory and labeling requirements; assure compliance with client and external standards and help drive implementation across functions and projects.
  • Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
  • Effectively perform gap analysis and propose solutions.   Develop and document sound regulatory decisions and justifications.
  • Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key global labeling strategies and initiatives.
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
  • May provide matrix or project related supervision of individuals
 
  1. Sound basis of global regulatory knowledge. Expert device labeling requirements and implementation will be an advantage.
  2. Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills.
  3. Strong oral and written communication and presentation skills
  4. Demonstrated interpersonal skills including strong negotiation and facilitation skills
  5. Ability to independently identify compliance risks and escalate when necessary
  6. Ability to lead and coach others
  7. Bachelor's degree in Regulatory affairs or equivalent with 5+years of regulatory experience and 8+ years of related professional experience in related field(s), including managing people or projects.   Direct experience with global device labeling will be an advantage.