Description
Senior Regulatory Affairs SpecialistThe Regulatory Affairs Specialist compiles and writes submission documents for product approvals for the US FDA and Health Canada. Participates as a member of a product development team to provide regulatory support to the project.
* Proactively participate and partner with R&D, Marketing and other required groups to assess and compile appropriate technical documents for regulatory submissions in support of the development project.
* Develop and maintain the Technical File for the project.
* Provide training and guidance to product development teams regarding specific product submission requirements.
* Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
* Identify appropriate standards for application in support of product development.
* Maintain current understanding and expertise with regard to new regulatory guidance and implement programs cross functionally to ensure compliance.
* Provide input and subject matter expertise regarding product recalls or advisory notices, CAPA investigations, and risk assessments.
* May partner with international regulatory affairs to support distribution markets to coordinate product registrations.
* Participate in ensuring a global regulatory team approach.
* Assess regulatory impact on post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
To find out more about Real please visit www.realstaffing.com