Quality and Regulatory Specialist

DFW-based Medical Device Manufacturer has an opening for a Quality and Regulatory Specialist. This position will perform the following functions while conforming to Ferris policy and procedures and ensuring compliance with national and international laws and ***** assist in assuring the quality of all products and manufacturing; serve, support, and advise internal departments; and serve customer needs and expectations. This position reports to the Manager of Quality & Regulatory.Essential DutiesPrepare 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.Write NCRs and CAPA's and resolution.Review production records.Plan and participate in audits with external regulatory agencies, suppliers and customersParticipate in post market surveillance and recall activitiesCooperate with top management and department supervisors to promote training, implementation, and enforcement of department proceduresParticipate in addressing and resolving technical problemsSupport Manufacturing, Product Development, Marketing, and SalesSupport international partners with documentation for registration of productsEditing and/or drafting policies, procedures, work instructions, specifications, technical documentation, recordsAssist with product complaints and resolutionsAssist 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.Other duties as assignedQualifications and Skill SetBS in Science or Engineering at a minimum, MS or MBA a plus2+ years quality and/or regulatory management in the medical device industry desirableExperience with the use of QMS Software. MasterControl is a plus.Exceptional problem-solving skillsProficient with MS Excel and MS WordKnowledge of and 510(K) SubmissionsExperience in ISO 13485 MDSAP and RegistrationExperience with Medical Device ***** Technical Documentation and EU MDRHealth Canada SORCertificate to Foreign Government Application & Approval Process***** Salary commensurate with experience and achievement.Company DescriptionFerris has been Manufacturing and distributing the innovative PolyMem wound-care products worldwide for 32 years. Ferris has received numerous awards including the KPMG Peat Marwick High-Tech Entrepreneur Award and Diagnostic Industry's Medical Design Excellence Awards.Ferris Mfg. Corp. established in 1977 is dedicated to the development and manufacturing of innovative wound-care products for the world professional health care market. Ferris is committed to providing innovative and superior quality products and services to our customers. This position is located in our headquarters and manufacturing facilities in Fort Worth, TX.

Created: 2025-06-05