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Regulatory Affairs Manager

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Date: Jun 11, 2021

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Regulatory 

Summary:

The Regulatory Affairs Manager develops and implements regulatory strategies to assure timely commercialization of new products in compliance with applicable regulations and standards.  The Regulatory Affairs Manager works collaboratively with cross-functional business partners to execute global strategies, and with external regulatory authorities managing submissions through to approval.   

 

The Regulatory Affairs Manager will maintain proficiency on regulations and provide continuing regulatory education and dissemination of regulatory information to the cross-functional business teams including new product development, global marketing, and clinical groups.

 

Responsibilities:

  • Serves as a strategic business partner working across functions to support new product development efforts.  Sets regulatory strategy and guides data development, review and compilation of appropriate technical information for new product submissions, including pre-market notifications, CE documentation and other global regulatory requirements.
  • Develops training, provides regulatory guidance, and acts as subject matter expert, to project teams regarding specific product submission strategy, related regulations/guidance and regulatory requirements
  • Responsible for 510k and MDR submissions to regulatory agencies
  • Manages Regulatory Agency interactions to expedite responses to agency queries and approval of applications. 
  • Evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives with minimal guidance
  • Reviews product labeling and promotional materials to assure compliance with regulatory requirements and consistency with product indications and classification.
  • Provides direction, oversight and ensures quality for Regulatory Affairs projects, assuring that project and business objectives are met in a timely and cost efficient manner
  • Determines regulatory impact of product changes and supports timely registration and approval of these changes with governmental agencies worldwide
  • Possesses deep knowledge, and ability to apply understanding, of medical device regulations
  • In depth knowledge of GMP

 
Requirements:

  • Bachelor's degree in scientific discipline required, M.S. preferred.
  • Minimum 8 years Regulatory Affairs is required
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • Demonstrated knowledge and effective application of regulations and standards for the US and EU, including US FDA medical device clearance process, the Medical Device Directive, ISO 13485, ISO 14971 and ISO 10993.
  • Strong knowledge of 510k submissions and MDR submissions
  • Strong written and verbal communication skills, including the ability to clearly and concisely articulate complex concepts to a lay audience.
  • Strong interpersonal skills – able to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
  • Demonstrated ability to spot issues and provide incisive, practical and business-focused support and advice.
  • Demonstrates an ability to apply new approaches to problem solving
  • Demonstrates an interest in and understanding of industry developments and trends
  • Project management skills a plus
  • Clinical Trial experience a plus
     

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.

 

Hollister is an EO employer – M/F/Veteran/Disability

Job Req ID: 29167


Nearest Major Market: Chicago

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