Very well-established and highly successful domestic and international medical device manufacturer has an exciting career opportunity for a highly talented and well-experienced Regulatory Affairs Specialist with FDA experience who will report directly into the Regulatory Affairs Manager.
Essential Functions and Responsibilities:
- Prepare & review documentation for internal product registration submissions including the interpretation & preparation of additional information as requested by International governments
- Maintain FDA establishment registration and device listings, including annual laser product reporting
- Maintain Health Canada establishment registration and device listings, including annual reporting
- Participate in FDA inspections & ISO audits
- Maintain knowledge of and ensure compliance to government and industry regulatory requirements
- Interpret and communicate changes to the regulatory requirements, and the impact they have on our current processes
- Maintain product files and product safety test reports to support compliance with regulatory requirements (i.e. UL file maintenance process)
- Maintain current external regulations & standards / compliance (ISO, Health Canada, EU, and JPAL, etc.) and monitoring regulatory environments
- Maintain domestic product registration and submission for the City of Los Angeles
- Prepare, maintain and submit technical files for CE registration
- Communicate the requirements for 510K submittal to appropriate cross functional teams to help facilitate continuous internal process improvement activities assuring compliance to regulatory requirements (i.e. GMP principles, SOP's)
- Oversee the day-to-day activities of company QMS with respect to compliance, documentation preparation and policy deployment
- Review of promotional materials, and labeling for compliance to regulatory requirements
- Write SOPs, Work Instructions and forms to support the QMS, and assuring compliance to regulatory requirements, including recommendations for updates when the regulations or standards change
- Communicate significant issues or developments identifies during quality activities and providing recommendations for process improvements to management
- Host UL FUS & 3 rd party audits (i.e. Truesdail, NSF, Intertek & IAPMO)
- Provide support during new product development, and design changes, on the regulatory requirements, exporting and labeling requirements, and compliance requirements
- Maintain list of approved international dealers, and products that are authorized, and registered, including their expiration dates
- Provide regulatory guidance and support to parent company on US FDA and Health Canada regulations
- Conduct internal audits of QMS including product and production processes
- Prepare and conduct regulatory affairs training to personnel
- Prepare and report quality metrics
- Performs other duties, as assigned
- 3-5 years' experience in Regulatory Affairs, Quality Assurance or Quality Systems within a FDA regulated industry
- Working knowledge of GMP principles
- Working knowledge of 21 CFR 820, ISO 13485, CMDR, European Council Directive
- 4 Year College Degree or practical experience in Regulatory Affairs or Quality Assurance
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
