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Manager Regulatory Affairs

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Date: Nov 26, 2021

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Regulatory 

 

Summary:

 

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

 

The Manager, Regulatory Affairs maintains proficiency on regulations and provides continuing regulatory education and dissemination of regulatory information to the cross-functional business teams including new product development, global marketing, and clinical groups. This position has 3 direct reports.

 

Responsibilities:

 

  • Leads the Regulatory Affairs – Continence Care Team, who is responsible for supporting new product commercialization efforts.  Manages resource commitments for team, ensuring adherence to budget, scope and schedule commitments.
  • Promotes and role models proactive and effective collaboration and communication within the team and cross-functionally.
  • Recruits, retains and develops talented new team members, gives performance feedback, conducts performance reviews and builds meaningful development plans to ensure high employee engagement, empowerment and performance.
  • Serves as an effective business partner who works with cross-functional team members 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
  • Consults with internal and external resources during the investigation of regulatory strategy for global projects, and corporate initiatives.
  • 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 and GXP

 

Requirements:

 

  • Bachelor's degree in scientific discipline required, M.S. preferred.
  • Number of relevant years of experience necessary: 8-12
  • Five years Regulatory Affairs experience minimum
  • Supervisory experience preferred
  • 510k Submission and EUMDR submission experience required   
  • 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 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 healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider Inc (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

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


Job Req ID: 29598


Nearest Major Market: Chicago

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