Principal Regulatory Affairs Specialist

Job description

Summary of Duties:

This position is responsible for coordinating, preparing, and maintaining regulatory submissions on a global level and assisting with departmental policy and procedure implementation.  Primary responsibilities are to ensure regulatory compliance for assigned product lines as the company evolves. Other responsibilities include providing technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams, maintaining and enhancing cross-functional team relationships, identifying relevant standards and guidance documents that affect the company’s business and products, assisting with regulator facility inspections, conducting internal audits when directed.


  • Determines global regulatory pathways for various projects for EU, US and International product launches / product enhancements
  • Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation
  • Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities)
  • Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies
  • Interacts directly with international regulatory agencies on products / projects at reviewer level and elevates significant issues to management
  • Prepares IDEs, assists with clinical trials and provides information regarding clinical requirements for international submissions, when required
  • Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel
  • Interacts with various levels of management, external agencies and companies
  • Analyses and makes recommendations regarding complaints received by the company and whether they are MDR, MPR or Vigilance reportable in markets; participates in complaint related meetings
  • Provides support for commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure
  • Assists with departmental policy implementation
  • Maintains and enhances cross-functional team relationships
  • Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams
  • Develops, maintains and analyses department systems and provides training when needed
  • Maintains expertise in worldwide regulatory requirements; establishes and maintains positive relationships with regulators
  • Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed
  • Performs other related duties and tasks, as required            

Summary of Minimum Qualifications:

  • Education and experience equivalent to a Bachelor’s Degree in the biological, physical, engineering or material science disciplines and 7 years of related experience
  • Demonstrated knowledge of global regulatory requirements with emphasis on U.S. FDA regulations, EU Regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
  • Must have experience working with regulatory agencies and submission 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
  • Excellent analytical and problem-solving skills
  • Demonstrated excellence in submission writing and preparation
  • Demonstrated computer skills preferably spread sheets, word processing, database, internet research and other applicable software programs


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent