Quality & Regulatory Specialist

Performance Health is seeking a Quality & Regulatory Specialist to join our team. In this role, you will be responsible for supporting with the maintenance and execution of an effective Quality System, and in ensuring medical products and their associated documentation is compliantly created, registered, and maintained in accordance with applicable global regulations.This position will be hybrid - working a few days per week at our Cedarburg, WI facility or at our corporate office in Warrenville, IL. Candidate must reside in the greater Milwaukee area or Greater Chicago area.Essential Job Duties & ResponsibilitiesSupport multiple sites in investigating & effectively driving to resolution medical product quality nonconformances, complaints, and CAPAs, Lead the identification of quality trends requiring prioritization through proactive data analysisAssist manufacturing sites with process verification & validation activities such as IQ, OQ, & PQActively participate in qualification of suppliers and performing periodic auditsSupport external regulatory audits & inspections, and participate as subject matter as applicableLead the investigation & reporting of complaints that either have, or may result in serious injurySupport maintaining global establishment & medical device, drug, & cosmetic registrations/listings Ensure product labeling claims are accurate, substantiated, & compliant with applicable regulationsSupport the creation & maintenance of EU Declaration of Conformities and Technical FilesSupport the creation of Post Market Surveillance reports and Clinical Evaluation ReportsDrive global regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug productsPreparing, obtain, and maintain global regulatory documents required to secure global licenses, and registrations such as legalization/apostille of documents and CFGs.Provide RA & QA education and training to company employees, as neededPerforms other duties as assigned Job Qualifications Bachelor’s Degree in Pharmaceutical, Life Sciences, Engineering or other related field 5+ years of developing and successfully defending complex regulatory submissions for medical devices and drugs 5 years of Quality/Regulatory experience within a medical product regulated industry Proven experience effectively interacting 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 countries. E.g. UK MDR 2002, (EU) 2017/745, SFDA Medical Device LawGood understanding of Quality System regulations such as FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standardsPrefer experience interacting with the FDA and other global regulated bodies in fulfilling requests for information and securing licenses and registrationsAbility 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 leaves; wellness programs; discount purchase programs.This is a full-time position with a base salary range of $80,000 - $95,000 and the opportunity to earn bonus, plus benefits. To perform thi