Regulatory Specialist

Company Description Ferris Mfg. Corp. is a privately owned medical device company specializing in PolyMem® multifunctional wound care dressings, which are designed to cleanse, fill, absorb, and moisten wounds throughout the healing process. Since 1977, Ferris has focused on developing innovative products that support effective and efficient wound healing outcomes. The company has received multiple industry awards recognizing its product design, growth, and export achievements. Ferris maintains a robust Quality System that meets or exceeds regulatory standards in the United States, Canada, the European Union, and other global markets. The company headquarter is in Fort Worth, Texas. Role Description The Regulatory Specialist is a full-time, on-site role based at Ferris Mfg. Corp.’s headquarters in Fort Worth, TX. This role is responsible for supporting regulatory submissions, product registrations, and compliance with domestic and international medical device regulations. Collaborated with cross-functional teams to ensure regulatory requirements were met throughout the product lifecycle while contributing to quality system maintenance and continuous improvement. Essential Duties Prepare and submit regulatory documents to appropriate agencies for registrations. Support compliance with local, national, and international regulations. Support internal audits and external audits. Keep current with changes in relevant regulations and standards. Compose CAPAs related to compliance. Support Manufacturing, Product Development, Marketing, and Sales. Support international partners with documentation for registration of products. Editing and/or drafting policies, procedures, work instructions, specifications, technical documentation, records. Assist with product complaints. Assist work with clinical staff to generate PMS, CER, PSUR, PMCF reports. Monitor laws, regulations, standards, marketplace, and culture for effects on Ferris and quality system. Write gap analyses. Communicate with Manager and consultants on developing a strategy. Other duties as assigned. Requirements Bachelor’s degree in a related field (e.g., Scientific Discipline, Engineering, pre-Law). Minimum of 2 years of experience in quality assurance, regulatory affairs, or a related role for medical devices. Examples of relevant regulatory requirements and quality standards - ISO 13485, FDA QMSR and Title 21 Subchapter H, EU MDR Regulations, ISO 14001, ISO 14971, etc. Strong attention to detail and excellent organizational skills. Effective communication and interpersonal skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite and relevant quality management software. Technical writing is preferred. #J-18808-Ljbffr Ferris Mfg. Corp.