Principal Regulatory Affairs Specialist - REMOTE

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**PRINCIPAL REGULATORY AFFAIRS SPECIALIST - RENAL CARE GROUP**
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
The Renal Care Group, within the Minimally Invasive Therapies Group, brings together Medtronic and Covidiens experience in advancing renal care through innovative design. Dialysis presents a unique set of challenges. Vascular access is critical to treatment and vulnerable to clotting and infection, some of the leading causes of catheter failure. We are leading the way by providing clinical solutions. Our acute, chronic and peritoneal dialysis catheters are designed to improve flow rates, reduce the risk of clotting, increase patient comfort and provide ease of use for clinicians. Our catheters help you meet the clinical demands of treating patients who need hemodialysis, apheresis, infusion, central venous pressure monitoring and high-pressure contrast injection.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
Whatever your specialty or ambitions, you can make a difference at Medtronic both in the lives of others and your career.
**Careers that Change Lives**
The **Principal Regulatory Affairs Specialist** provides regulatory support for new product development submission activities and post-market support for existing products. Responsibilities include implementing worldwide regulatory plans, supporting regulation changes and completion of regulatory deliverables. More specifically, the Principal Regulatory Affairs Specialist is also responsible for managing international regulatory registrations with the Regional teams, which includes creating with assistance global regulatory strategies and impact assessments, track registrations, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
Responsible for global submissions requirements related to changes.
Drive the preparation, publication, quality control, and delivery of technical documentation required for full compliance with the EU MDR and associated submissions.
Assist in the development, documentation, and implementation of regulatory strategies for product modifications to include all applicable regulatory requirements.
Effectively plan and drive successful completion of cross-functional projects for global project (i.e., procedure updates, standard submissions or labeling change).
Perform coordination and preparation of document packages for regulatory submissions
Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitor, track and provide project updates
Create and coordinate Product Change Notification using Agile
Oversee the submission of International Registration Documents and progress
Act as liaison with International regulatory personnel to address questions and issues that arise as part of the registration and/or testing process.
Assess product impact based on new and changing regulatory requires.
Obtain and maintain CFGs/FSCs including the notarization and legalization, EC/ISO Certs and various other regulatory documents.
Maintain and update Regulatory database (used for tracking of international registration requests) as administrator.
Develop and maintain product technical files/STED.
Build submissions in Agile for ease of access and maintenance
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
Establish and maintain a professional and credible image with FDA, notified bodies, and other regulatory agencies.
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.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Perform other duties as assigned
**Must Have: Minimum Requirements**
Bachelors degree in a scientific or engineering discipline
Minimum of 7 years of experience in the medical device industry with Regulatory Affairs/Quality Assurance
OR an advanced degree with a minimum of 5 years of experience in the medical device industry with Regulatory Affairs/Quality Assurance
**Nice to Have**
Product experience including implantable products (catheters preferred) and/or dialysis therapies
Experience with software systems such as Agile
Medical device Regulatory experience
Working knowledge of global medical device regulations, including submissions.
Demonstrated Microsoft Word, Excel and Adobe software skills.
Experience working with cross-functional teams.
Experience working with technical documentation/STED.
Effective verbal and written communication skills.
Experience with solving problems and concerns.
Experience with project management and adherence to time schedules.
Work well under pressure in a dynamic environment.
Ability to multi-task effectively in a fast-paced environment
Highly organized, detail-oriented, and efficient.
Team player who seeks to help and learn from colleagues seeing the department success as their own
Ability to manage small-scale projects to completion within and outside of the direct department.
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Proactively seeks to develop and become well-versed within the regulatory landscape.
Regulatory Affairs Certification
**About Medtronic**
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
**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. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Categories
Healthcare
Management
Manufacturing / Production
Engineering
Financial Services
Marketing
Administrative / Clerical
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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