Great opportunity for a Regulatory Affairs Specialist to join this top medical device company, to be part of their new product growth team. The Regulatory Affairs Specialist position will be part of developing parts for the medical device industry based in Miami. Get in on the ground floor of this new team/department with this long-term contract job.
The Regulatory Affairs Specialist will integrate strategies to support commercial product maintenance for IVDR remediation. As a regulatory process expert to development teams, the incumbent support global registrations and compliance activities; provides regulatory review of promotional material, experimental designs, data analysis and product labeling as related to registration and commercialization of medical devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees to develop harmonized policies, procedures and documentation for emerging IVDR regulatory compliance.
Requirements of the Regulatory Affairs Specialist are:
- Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 years of experience in the offered position.
- Must have experience with Global Registrations and CE Mark documentation
- Experience implementing premarket regulatory strategy.
- Experience writing and submitting premarket submissions to regulatory agencies.
- Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
- Experience applying 21 CFR 801, 803, 806 and 820 regulations.
- Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.
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