Performance Health
Location
Warrenville, IL | United States
Job description
Performance Health is seeking a Regulatory Affairs Specialist to join our team. This role is responsible for establishing & maintaining global regulatory registrations & listings, ensuring products & associated documentation/labeling are in compliance with applicable regulations, and performing proactive regulatory intelligence to identify & implement action plans to ensure timely compliance with upcoming regulatory changes.This is a hybrid position working 1-2 days per week in our corporate office in Warrenville, IL. Essential Job Duties & ResponsibilitiesMaintain global establishment & medical device, drug, & cosmetic registrations & listings Ensure product labeling claims are accurate, substantiated, documented, & compliant with applicable regulationsAssist with the creation & maintenance of EU Declaration of Conformities and Technical FilesAssist with the creation of Post Market Surveillance reports and Clinical Evaluation ReportsInteract with EU & Swiss Authorized Representatives as requestedProvide support for medical device and drug classification in global marketsAssist with global regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug productsPrepare and maintain global regulatory documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner such as legalization/apostille of documents and CFGs.Assist with the investigation and reporting to global regulatory authorities of product complaints that either have, or may result in serious injury 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 actionsProvide education and training on regulations to company employees, as neededPerforms other duties as assigned Job Qualifications Bachelor’s degree in Pharmaceutical, Life Sciences, Engineering or other related technical fieldMinimum of 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugsProven experience building effective relationship with the FDA and other international regulatory bodies including the EU and Health CanadaExperience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodiesStrong knowledge of global country specific regulations required for registering and marketing products for sale in applicable countriesUnderstanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standardsAbility to travel up to 10% of the time, including overnight travel BenefitsOur benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parenting
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