Job Description:

Regulatory Affairs SpecialistSalary Range: $90,000.00 To 110,000.00 AnnuallyAbout the Opportunity: The Regulatory Affairs Specialist will work in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licensing, registrations and inspections in compliance with local, state, national and international regulatory this role, the successful candidate:• Maintains Regulatory Affairs certifications for domestic and international customers and distributors.• Reviews document changes, product labeling and in-house procedures to ensure regulatory requirements are met.• Prepares for and facilitates internal, external, and third-party audits as necessary.• Researches and responds to internal and external customer requests for regulatory information.• Interfaces with the FDA concerning issuing Certificates to Foreign Government for The company Corporation and its subsidiaries as needed.• Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The company and its subsidiaries interfacing with Notified Bodies.• Maintains Declaration of Conformities for all company products and its subsidiaries.• Communicates with the Secretary of State office, Department of State and Foreign Embassies or Consulates regarding authentication of documents to support the registration process.• Supports product registration for company's International Branches to meet foreign requirements for China, Canada, Taiwan, Korea, and others.• Provides and submits regulatory documentation to notified bodies and Authorized Representative to support MDDMDR requirements.• Represents Regulatory Affairs and Quality team in yearly audits for quality and regulatory documentation including Technical Documentation.• Contributes to Regulatory projects and deliverables to ensure company remains compliant to MDR and ISO requirements.Qualifications:• Bachelor's degree and 5+ years of progressive experience in quality assurance and regulatory experience, or equivalent combination of education and experience.• Experience in the medical device industry preferred.• Ability to comprehend and follow technical work instructions and standard operating procedures. • Working knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR98-282, 9342EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred• Strong problem solving, administrative, and data management skills.• Demonstrated attention to detail.• Team player with ability to work independently.• Ability to multi-task, work under pressure and meet deadlines.• Strong written and verbal communication skills.• Maintain certification for California Notary Public.