The Associate Regulatory Affairs Specialist provides regulatory support for domestic and international submissions; provides responses to routine requests for information or documentation for new or existing product support; interacts with various functional groups within Medtronic to ensure regulatory requirements are defined and followed.
A Day in the Life
Team with other Regulatory Affairs Specialists to provide regulatory support for new products and changes to existing products. Activities include working with Regulatory Specialists and other cross functional team associates to develop worldwide regulatory compliance deliverables new products and/or changes as required.
Work with global market managers to develop regulatory plans for product registration (plans include required documents, testing and submission/approval schedules); review required documents to ensure they are appropriate for submissions; work with Regulatory Affairs associates, engineers, and technical experts to resolve questions and issues; coordinate approval documents from countries.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Provide regulatory support for post market activities for product lines including, reviewing and approving Change Orders for product lines in a timely manner and completion of preventive or corrective actions or other Quality tasks, as needed.
Develops solutions to routine problems of limited and moderate scope and complexity. Participates in planning and problem solving discussions. Limited use and application of technical or regulatory principles, theories and concepts.
Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Follows specific instructions and procedures for assigned tasks. Work is closely supervised.
Communicates and interfaces primarily with immediate supervisor, project leaders, and other professionals within the regulatory group. Some interaction with other cross functional groups within Medtronic.
Other tasks, as assigned.
Must Have: Minimum Requirements
0 years or more of experience in regulatory affairs or related field
Experience with internet/intranet technology and interactive software applications
Competency with Microsoft Office applications and Adobe Acrobat
Nice to Have:
Advanced Degree or Law Degree
Prior regulatory experience or exposure and knowledge of global regulatory requirements
Experience working with cross-functional teams
Experience working with technical documentation
Effective negotiating skills and demonstrated written/oral communication skills
Degree in scientific or technical discipline
Strong organizational skills
Ability to multitask, support multiple projects, and meet project deadlines
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.