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Regulatory Affairs Specialist

Compliance & Regulatory Manufacturing & Distribution Roselle, Illinois, US
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Performance Health is seeking a Regulatory Affairs Specialist to join our team.  This role responsible for implementing global product Regulatory strategies and processes across Performance Health that are focused on ensuring compliant, timely, and cost-effective submissions to get needed licenses, registrations, and listings for medical devices and drugs.  

To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties & Responsibilities

  • Lead timely execution of Regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products
  • Assist with providing leadership to global business in the preparation of regulatory submission documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner
  • Assist with the development of effective long and short-term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations
  • Ensure accuracy of Declaration of Conformity for EU in conjunction with Authorize Representative and provide support for medical device and drug classification in global markets
  • Review product and labeling/claims changes to maintain regulatory compliance
  • Maintain regulatory records by updating corporate databases, recording and filing appropriate regulatory registrations and submissions
  • Ensure product labeling and claims are accurate, substantiated, documented, and compliant with applicable regulations
  • Oversee and maintain site establishment registrations and certifications
  • Monitor domestic and international regulatory developments changes that may potentially impact the company’s products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actions
  • Provide education and training on regulations to company employees, as needed
  • Investigate and report to global regulatory authorities (as required) product complaints that either have, or may result in serious injury
  • Performs other duties as assigned

Job Qualifications

  • Bachelor’s degree in Pharmaceutical, Life Sciences, Engineering or other related technical field
  • Minimum of 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs
  • Proven experience building effective relationship with the FDA and other international regulatory bodies including the EU and Health Canada
  • Experience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodies
  • Strong knowledge of global country specific regulations required for registering and marketing products for sale in applicable countries
  • Understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
  • Ability to travel up to 10% of the time, including overnight travel

Performance Health is an Equal Opportunity/Affirmative Action Employer.  All qualified applicants will receive consideration for employment

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  • Manufacturing & Distribution, Roselle, Illinois, United StatesRemove