Associate Regulatory Affairs Specialist

A Day in the LifeResponsibilities may include the following and other duties may be assigned:Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.Leads or compiles all materials required in submissions, license renewal and annual registrations.Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.Monitors and improves tracking / control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.DIFFERENTIATING FACTORSAutonomy: Entry-level individual contributor on a project or work team. Works with close supervision.Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.Leadership and Talent Management: N / A – job at this level is focused on self-development.Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.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.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).