Senior Regulatory Affairs Specialist

Job Overview

Job title: Senior Regulatory Affairs Specialist
Location: Galway city
Type: full time, permanent
Industry: medical device

Job spec:
I am delighted to be working with one of the best employers in Galway, and if you are a Senior Regulatory Affairs Specialist you could be working for this company soon too. You could be Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries.
Primary responsibilities are to ensure regulatory compliance for assigned product lines. Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect Merit's business and products, assisting with FDA facility inspections, Notified Body audits, and other internal audits. Performs duties with limited input from management and/or senior members of the department.


Main duties & responsibilities:

  • Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
  • Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
  • Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities and /or Distributors.
  • Prepares IDEs and PMAs and assists with clinical trials when required.
  • Interacts with various levels of management, external agencies and companies.
  • Analyzes and makes recommendations regarding field complaints.
  • Develops, maintains and analyzes department systems and provides training when needed.
  • Remains current on developing regulations and revises systems as necessary.
  • Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
  • Assists with supervision of department staff, as directed.
  • Performs other related duties and tasks, as required.

Main requirements & experience

  • Education and experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
  • Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
  • Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills.
  • Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
  • Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

COMPETENCIES

  • Regulatory submission/rationale preparation/publishing
  • Global Regulatory paths/strategies
  • Computer skills/internet research
  • Interpersonal/communication skills
  • Regulatory system development/training
  • Field Action coordination and reporting
  • Product development and change qualification processes

To apply for this position, please submit your CV (in Word format) now through this website in the strictest of confidence

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