Description
The Regulatory Affairs Specialist compiles and writes submission documents for product approvals for the US FDA and Health Canada. These documents include 510(k) Premarket Notifications, Investigational Device Exemption applications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports. This position works with program teams in identifying regulatory requirements early in the new product development process. 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.
* Write submission documents for FDA and Health Canada, compile information and write responses to questions from reviewing agencies.
* 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.
* Communicate with customers to respond to regulatory concerns/questions as required.
* May maintain product registration data base for foreign registrations.
* May partner with international regulatory affairs to support distribution markets to coordinate product registrations.
* Participate in ensuring a global regulatory team approach.
* May review or provide input to regulatory department metrics.
* May recommend and or implement process improvements and updates to regulatory department SOP's.
* Assess regulatory impact on post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
* Conduct field actionsDesired Skills and Experience
Education and Experience Requirements
* Minimum of a B.S. degree in a technical discipline
* 5+ years experience in regulatory affairs within the medical device industry, including writing 510(K) clearances
* Must have proven experience in FDA submissions
* CE technical file requirements experience preferred
* Must have a thorough understanding of FDA's premarket notification requirements and Canadian medical device licensing procedures
To find out more about Real please visit www.realstaffing.com