Medtronic is an Equal Opportunity/Affirmative Action Employer
Provide regulatory support for domestic submissions. Provide responses to routine requests for information or documentation for new or existing product support. Interact with various functional groups to ensure regulatory requirements are defined and adhered to.
Team with other Regulatory Affairs Specialists to provide regulatory support for changes to existing products and new products. Activities include working with Specialists and other cross functional team associates to develop regulatory plans and deliverables list for product changes; reviewing documents required for submissions to ensure they are appropriate for submissions; working with Regulatory Affairs associates, engineers, and technical experts to resolve questions and issues; coordinating approval documents from countries.
Provide regulatory support for post market activities for assigned product lines including, reviewing and approving Change Orders for assigned product lines.
Provide assistance and support to other regulatory affairs associates as necessary.
Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Other tasks, as required.
Bachelor’s Degree with 2-4 years industry regulator experience
or advanced degree with 0-2 years industry experience and some regulatory,product development,engineering or clinical experience
Effective verbal and written communication skills.
Effective organizational skills.
Experience with solving problems and concerns
Attention to detail.
Working knowledge of FDA
Prior regulatory experience or exposure.
Experience working with cross functional team.
Experience working with technical documentation.
Effective negotiating skills.
Experience with project management and adherence to time schedules.
Quality or Regulatory compliance experience or background.
Demonstrated writing/technical writing skills.
Physical Job Requirements
Must be able to sit/stand/walk 8 hours per day.
Vision must be correctable to 20/20 in one eye.
Must be able to lift ten pounds. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...