Medical Devices
Medical Devices

Regulatory Affairs Associate

Long Island, New York

Scope

Our client is the US manufacturer of choice of products for the dental professional to be “equipped for life”. They leverage their market leadership position in core practice equipment to become a leading producer of digital diagnostic systems, hygiene solutions, and other relevant product categories. Furthermore, they apply their technologies to create innovative solutions for select non-dental markets. As their business continues to grow, they are on the look for a self-motivated, driven Regulatory Affairs Associate based in Long Island, New York.

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 air and report quality metrics
  • Performs other duties, as assigned

About You

  • 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
  • Educational Requirements
  • 4 Year College Degree or practical experience in Regulatory Affairs or Quality Assurance
If you are interested in the above role then please apply or get in touch to discuss further.
Oscar Minshull Managed by Oscar Minshull
highlights
International
Permanent
Technical
apply Posted - 14.06.2022

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Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.