Regulatory Affairs Specialist

  • location: Miami, FL
  • type: Permanent
  • salary: $170,000 - $175,000 per year
easy apply

job description

Regulatory Affairs Specialist

Job Title: Director of Global Regulatory Affairs and Quality Assurance - Medical Device

Position Description

The Director of Global Regulatory Affairs and Quality Assurance is responsible for strategic and operational leadership for the Regulatory Affairs function globally across multiple product development / manufacturing sites as well as Commercial Regulatory and Quality Assurance for China.

Globally, this position will provide direction for regulatory affairs programs including new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements. In China, this position will oversee the quality management system, quality assurance program for warehouse and distribution functions, reagent and instrument product registrations, regulatory agency certification for storage and distribution of In Vitro Diagnostic medical devices.

Position Responsibilities

  • Build and develop a high performing regulatory affairs and quality assurance team
  • Provide strategic direction for new product development regulatory strategies aimed at improving time to market globally
  • Direct and oversee commercial regulatory and quality operations in China
  • Direct and oversee the regulatory and quality planning processes with responsibility for strategic and tactical planning processes
  • Oversee and ensure efficient processes for global registrations and post market compliance
  • Oversee program to ensure readiness for EU IVDR compliance
  • Direct and oversee program for review and approval of marketing communication materials
  • Monitor project progress and provide reporting on a regular basis to executive management to ensure timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities
  • Participate in corporate councils setting strategy for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively
  • Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively
  • Utilize tools to drive compliant and effective processes; improve capability to support market growth
  • Develop resourcing strategies, allocates budgets, staff, tools and support necessary for efficient and compliant operations
Position Requirements

  • Bachelor's degree in areas of life sciences, engineering, or quality assurance; advanced degree preferred
  • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
  • 20 years' experience in a regulated medical device/diagnostic industry (fewer years' required with advanced degree)
  • 10 years' supervisory and management experience
  • Demonstrated experience in developing organizational capability
  • Proven track record of bringing together the quality and regulatory functions across multiple locations to create an organization that supports the business worldwide
  • Demonstrated successful experience negotiating complex premarket and post market regulatory strategies with FDA, CFDA and other regulatory agencies
  • Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations
  • Knowledge of design control process requirements and requirements for technical documentation for medical devices
  • Global experience leading and/or participating on cross functional teams
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

easy apply

get jobs in your inbox.

sign up

related jobs

    SOX Testing Specialist

  • location: Miami, FL
  • job type: Contract
  • salary: $40 - $65 per hour
  • date posted: 9/28/2018

    Payroll Specialist

  • location: Miami, FL
  • job type: Contract
  • salary: $20 - $24 per hour
  • date posted: 10/19/2018