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 & Responsibilities

• Maintain global establishment & medical device, drug, & cosmetic registrations & listings
• Ensure product labeling claims are accurate, substantiated, documented, & compliant with applicable regulations
• Assist with the creation & maintenance of EU Declaration of Conformities and Technical Files
• Assist with the creation of Post Market Surveillance reports and Clinical Evaluation Reports
• Interact with EU & Swiss Authorized Representatives as requested
• Provide support for medical device and drug classification in global markets
• Assist with global regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products
• Prepare 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 actions
• Provide education and training on regulations to company employees, as needed
• 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

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 - $90,000 plus benefits.

To perform this job successfully, an individual must be able to perform each essential job duties 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.