Director, Regulatory Affairs
AngioDynamics, Inc. - Marlborough, MA

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Position Summary:

Liaison with International Regulators and In-country Regulatory Partners to develop and implement international country specific Regulatory strategies to achieve business objectives.

Position Responsibilities:
  • Provide technical guidance and support for development of Regulatory submissions consistent with country-specific requirements in Intercontinental countries, APAC, LATAM.
  • Collaborate with Regulatory Franchise Directors to Develop International Regulatory strategies for existing and new products registrations.
  • Collaborate with International Sales and Marketing.
  • Direct and coordinate resources related global submission activities.
  • Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.
  • Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation.
  • Establish project priorities to meet business objectives.
  • Support and maintain Quality initiatives in accordance with Quality Policy.
  • Continuously assess ways to improve Quality.
  • Advise team of prevailing and evolving global regulatory requirements and environment.
  • Develop, implement, and maintain policies and procedures.
  • Coordinate post-market approval activities.
  • Foster employee career development.
  • Participate in trade and professional organizations.
  • Provide training to manufacturing and development teams on key global technical documentation / data requirements.
  • Manage in order to ensure compliance with all relevant regulatory/legal requirements.
  • Establish project priorities to meet business objectives, develop and report metrics.
  • May perform other duties as assigned by supervisor.
  • Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support.
  • Ensure all employees are trained to do their work and their training is documented.

Required Skills
  • Extensive background in the development of regulatory submissions and documentation.
  • Excellent grasp of change control and test/validation requirements.
  • Strong strategic, decision‑making, and risk assessment abilities.
  • Highly developed written and oral communication, technical writing and editing skills.
  • Excellent organizational, leadership, and interpersonal skills.
  • Thorough knowledge of product development process and design control.
  • Knowledge of EU MDD, CMDR, PMDA/PAL, APAC Country requirements, LATAM
Required Experience
  • Bachelor’s degree.
  • Advanced degree preferred.
  • Professional regulatory certification(s) preferred.
  • 10+ years Regulatory Affairs medical industry experience preferred.
  • Demonstrated experience achieving regulatory approvals.

AngioDynamics, Inc. - 24 months ago - save job