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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