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Senior Regulatory Affairs Specialist - Renal Care Solutions

Medtronic
Minneapolis, MN 55405
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Senior Regulatory Affairs Specialist - Renal Care Solutions

Location:

Minneapolis, Minnesota, United States

Requisition #:

20000MHP

Post Date:

Jan 11, 2021


**SENIOR REGULATORY AFFAIRS SPECIALIST - Renal Care Solutions**


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.


Renal Care Solutions is a business within Medtronic that is working to advance dialysis and renal care through innovative design. 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.


**Careers That Change Lives**


This position will support a highly visible program that encompasses capital equipment, combination products, pharmaceuticals, and disposables. The **Senior Regulatory Affairs Specialist (Sr. RAS)** develops and executes strategies for global regulatory approvals to introduce new and modified medical devices, combination products and pharmaceuticals to the market. The Sr. RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies, as required. Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. Remote working can be considered.


**A Day In The Life**


+ Coordination, writing and preparation of regulatory submissions for global product registrations for new products and product changes. Review significant regulatory issues with manager, as necessary, and negotiate submission issues with regulatory bodies. Able to write regulatory justifications to support submission filing decisions.

+ Prepare regulatory strategies/plans and worldwide regulatory requirements. Communicate effectively with cross functional team as well as regulatory counterparts in other geographies to prepare and manage submission strategies, manage priorities in collaboration with the Marketing department.

+ Interface internally with QA, RD, Clinical and other affected departments to ensure timely availability of submission documents.

+ Provide regulatory input, review, and approval of protocols, reports, labeling, promotional materials, training materials, and other documents used in submissions.

+ Reviews, prepares and maintains regulatory files (administrative documents and technical documentation in format required by local laws, regulations, and standards) for new and/or changed products and submits to applicable authorities.

+ Assess changes to products for regulatory impact (US and EU) and complete associated documentation.

+ Maintain current domain knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the organization.

+ Establish and maintain professional working relationships with regulatory agencies.

+ Ability to travel internationally up to 10%.


**Must Have; Minimum Requirements**


+ Bachelors Degree

+ 4+ years of experience in the medical device industry with bachelors degree.

+ 2+ years of experience in the medical device industry with advanced degree.


**Nice To Have**


+ Bachelors Degree in scientific or engineering discipline

+ Preferred 5 years of experience in medical device regulatory affairs, quality, or engineering; working in a global environment (ideally working in project teams).

+ Experience with 510(k) products desired. IDE, De Novo or PMA experience in lieu of 510(k) experience is acceptable.

+ Experience in supporting Class III device or IIb active medical device European technical documentation and submissions

+ Strong working knowledge of the European Medical Device Regulation

+ Experience with negotiations/interactions with regulatory agencies/health authorities

+ Excellent analytical thinking and problem-solving skills

+ Ability to effectively manage multiple projects and priorities

+ Proven ability to lead and work effectively in cross-functional teams

+ Ability to work in matrix teams

+ Strong organization and time management skills

+ Demonstrated ability to influence based on experience, facts and data

+ Highly motivated and results-oriented leader

+ Project-management skills and experience

+ Detail-oriented, self-starter

+ Ability to be flexible with changing priorities

+ Submission-related word processing skills

+ Knowledge of Quality System requirements and FDA and/or International product approval process.

+ Highly proficient in spoken and written English.


**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)


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.


Learn more about our benefitshere (https://www3.benefitsolver.com/benefits/BenefitSolverView) .


This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .
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.

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Posted: 2021-01-14 Expires: 2021-05-21
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Senior Regulatory Affairs Specialist - Renal Care Solutions

Medtronic
Minneapolis, MN 55405

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