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 & Responsibilities

• Support 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 analysis
• Assist manufacturing sites with process verification & validation activities such as IQ, OQ, & PQ
• Actively participate in qualification of suppliers and performing periodic audits
• Support external regulatory audits & inspections, and participate as subject matter as applicable
• Lead the investigation & reporting of complaints that either have, or may result in serious injury
• Support maintaining global establishment & medical device, drug, & cosmetic registrations/listings
• Ensure product labeling claims are accurate, substantiated, & compliant with applicable regulations
• Support the creation & maintenance of EU Declaration of Conformities and Technical Files
• Support the creation of Post Market Surveillance reports and Clinical Evaluation Reports
• Drive global regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products
• Preparing, 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 needed
• Performs 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 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. E.g. UK MDR 2002, (EU) 2017/745, SFDA Medical Device Law
• Good understanding of Quality System regulations such as FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
• Prefer experience interacting with the FDA and other global regulated bodies in fulfilling requests for information and securing licenses and registrations
• Ability to travel up to 10% of the time, including overnight travel

Benefits

• Our 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 this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed above 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.

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity, sexual orientation, race, color, religion, national origin, disability status, protected Veteran status, age, genetic information, and any other characteristic protected by law.