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Principal Regulatory Affairs Specialist

Job description

Duties/Responsibilities:

  • 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.
  • Prepares IDEs, assists with clinical trials and provides information regarding clinical requirements for international submissions, when require while reviewing clinical trials and providing advice for submissions.
  • 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. Also advising engineers and technical experts on regulatory issues.
  • 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:   jporter@sigmar.ie  

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