Position Title
Regulatory Affairs Specialist
SBU
Corporate
Department
Regulatory Affairs
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Responsible for successfully compiling and managing domestic (510(k), IDE) and European regulatory submissions for final review by Engineering and Regulatory Management by...
Interacting with Product Development staff Gathering information from a variety of internal and external resources Serving on Product Development teams as a regulatory expert for specific product lines Evaluation labeling for appropriate regulatory content Reviewing content of submissions in detail for accuracy and consistency Negotiate approvals with regulatory agencies.
Qualification Requirements
Participate in and consult for the design control process for specific product developments
Stay current with relevant domestic and European regulatory requirements for medical devices including standards and guidance documents.
Perform job duties with limited supervision Maintain current status on assigned projects in Regulatory Affairs group project database Lead or participate in other projects as directed by management Lead other regulatory related projects as requested.
Preferred Qualifications
BA Degree required
Responsibilities
Responsible for determining regulatory requirement and creating submissions for US and International markets, in support of product development initiatives. Support the design control process for specific product lines and work directly with engineering and regulatory personnel to successfully obtain product approval.
