Regulatory Affairs Specialist

4 weken geleden

Maastricht, Limburg, Nederland Merit Medical Systems Inc Voltijd

Job Summary

This role is responsible for ensuring regulatory compliance for assigned countries as Merit evolves. The position will be based in Saudi Arabia and involves coordinating, preparing, and maintaining regulatory submissions and documents on a global level.

Key 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, approval timelines, and international submissions.
  • Identifies guidance documents, international standards, and assists teams with their interpretation.
  • Prepares regulatory submissions to regulatory authorities and/or distributors.
  • Interacts with various levels of management, external agencies, and companies.
  • Develops, maintains, and analyzes department systems and provides training when needed.
  • Remains current on developing regulations and revises systems as necessary.
  • Assists with facility inspections, Notified Body Audits, and other governmental inspections as directed.
  • Contributes to continuous improvement initiatives.
  • Assists with supervision of department staff, as directed.

Requirements

  • Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering, or material science disciplines and six years of related experience.
  • Demonstrated knowledge of global regulatory requirements, particularly in the GCC medical device regulations, and SFDA.
  • Good understanding of FDA regulations, EU regulations, and various Quality System Standards/Regulations/Laws, including ISO 13485.
  • Supervisory skills are preferred.
  • Demonstrated computer skills, preferably in spreadsheets, word processing, database, internet research, and other applicable software programs.

Competencies

  • International Regulatory requirements
  • Regulatory submission/rationale preparation
  • Medical device and vigilance reporting
  • Computer skills/internet research
  • Interpersonal/communication skills
  • Regulatory system development/training
  • Demonstrate organisational values in carrying out all assigned responsibilities/tasks.
  • 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.
  • Language skills: advanced English.

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