Senior Regulatory Affairs Specialist

Job description

In this job, you will coordinate, prepare, and maintain regulatory submissions on a global level to both European CE-marking and US FDA submissions. In this job, you will report to the Director of Regulatory Affairs

What You will Do:

  • Identify potential global regulatory pathways for various projects for EU, US and International product launches / product enhancements. Evaluate guidance documents, international standards, consensus standards and assists teams with their interpretation
  • Create regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).
  • Liaise directly with international regulatory agencies on products / projects at reviewer level.
  • Support commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes
  • Conduct technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Prepare & Conduct internal & external audits for regulatory bodies

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