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Regulatory Affairs Specialist

Company: Disability Solutions
Location: Libertyville
Posted on: March 20, 2023

Job Description:

We Make Life More Rewarding and Dignified Location: Libertyville Department: Regulatory Summary: The Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion. Hollister Incorporated operates in a hybrid work environment. Responsibilities:

  • Lead or represent Regulatory Affairs in project teams
  • Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements
  • Prepare, review, and approve department SOP's.
  • Provide regulatory advice to project teams.
  • Respond to regulatory authorities' queries within defined deadlines
  • Maintain regulatory files in a format consistent with requirements and stored in defined electronic system
  • Develop and initiate complex regulatory project plans
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner)
  • May review labeling and promotional material for compliance with local regulations
  • Maintain annual licenses, registrations and listings with FDA and Health Canada.
  • Independently investigates and reviews proposed regulations on a federal and state level (domestic and international) that affects the viability of Hollister Business
  • Independently investigates and review existing and proposed standards (ISO, EN, BSI, etc.) that are applicable to Hollister Business Requirements:
    • 5+ years' experience in a regulated industry (e.g., medical device, cosmetics, pharmaceutical). Higher education may compensate for years of experience
    • Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
    • Exercise independent judgment
    • Strong written and verbal communication skills
    • Knowledge of regulations and design controls
    • Developing negotiation skills
    • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
    • Ability to manage multiple projects and deadlines
    • Ability to identify compliance risks and escalate when necessary #LI-Hybrid Our Total Rewards package in aggregate is above market and includes competitive pay, generous paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP). 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. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 31301

Keywords: Disability Solutions, Chicago , Regulatory Affairs Specialist, Other , Libertyville, Illinois

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