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Principal Regulatory Affairs Specialist

Job Title: Principal Regulatory Affairs Specialist
Contract Type: Permanent
Location: Galway
REF: 94219
Job Published: 5 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Principal Regulatory Affairs Specialist

Our client, a medical device company in Galway are currently looking to recruit a Principal Regulatory Affairs Specialist for their site.

  • 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 in regard to 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 particular 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 as well as manage relationships within a cross functional team and regulators.
  • Excellent analytical and problem-solving
  • Strong experience in product submissions (sharp on EU and US regulations)
  • Strong interpersonal skills and ability to manage relationships within a cross functional team and regulators.

For further information on this Principal Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 /

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