Regulatory Operations Specialist

at  Medtronic

CAREERS THAT CHANGE LIVES

Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.

MUST HAVE: MINIMUM REQUIREMENTS:

• Bachelor’s Degree is required (preferably in Allied Sciences or similar disciplines)Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

PHYSICAL JOB REQUIREMENTS

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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

• Handle the preparation, publication, quality control, and delivery of paper and electronic components of all submissions, including initial large marketing authorization applications and electronic common technical documents (e-CTD).
• Ensure that submissions are produced with electronic publishing tools, in compliance with document management standards.
• Handle activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
• Ensure that continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
• Prepare, submit, track, and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials