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Regulatory Affairs Specialist

2 maanden geleden

Maastricht, Limburg, Nederland Merit Medical Systems Inc Voltijd

Job Summary

This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level, for Saudi Arabia and GCC region. Primary responsibilities include ensuring regulatory compliance for assigned countries as Merit evolves. Other responsibilities include product life cycle management in accordance with regional requirements, supporting vigilance and recalls, identifying relevant standards and guidance documents that affect Merit's business and products, assisting with facility inspections, Notified Body audits and other Regulator audits, conducting internal audits when directed and making recommendations as appropriate. This position will be based in Saudi Arabia.

Key Responsibilities

  • Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • Participates on various teams with the role of defining regulatory requirements, approval timelines etc. for international submissions.
  • Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
  • Prepares regulatory submissions to regulatory authorities and/or distributors (SFDA, and other GCC regulatory authorities).
  • 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.
  • Performs other related duties and tasks, as required.

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 with particular emphasis on GCC medical device regulations, notably SFDA.
  • Have a good understanding of FDA regulations, EU regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
  • Supervisory skills are preferred.
  • Demonstrated computer skills preferably spread sheets, 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 (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of 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.