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Senior Regulatory Affairs Specialsit

Medtronic


Location:
Miami Lakes, FL 33016
Date:
07-01-2021
2021-01-072021-02-14
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Job Details

Senior Regulatory Affairs Specialsit

Location:

Mounds View, Minnesota, United States

Requisition #:

20000M2G

Post Date:

Jan 04, 2021


**SENIOR REGULATORY AFFAIRS SPECIALIST**


In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.


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.


**Careers That Change Live**


The **Senior Regulatory Affairs Specialist** develops strategies for worldwide product registration with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce Mechanical Circulatory Support (MCS) products and changes to market, provides advice on regulatory requirements, prepares submissions and negotiates their approval. The Sr. Specialist also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.


**A Day In The Life**


+ Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.

+ Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.

+ Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.

+ Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.

+ Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.

+ Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.

+ Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Mechanical Circulatory Support (MCS) portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.

+ Work under general supervision following established procedures. Independently determines and develops approach.

+ Frequent inter-organizational contact and some external contacts.

+ Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.

+ Provide training and support to other members of the department.

+ Other tasks, as required.


**Must Have; Minimum Requirements**


+ Bachelors degree in a technical discipline

+ Minimum 4 years of experience in regulatory affairs or the medical device industry with Bachelors degree

+ Or Minimum 2 years of experience in regulatory affairs, or the medical device industry with advanced degree


**Nice To Have**


+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.

+ 4+ years medical device industry experience

+ In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

+ Experience with Class II medical devices (PMA)

+ History of successful device submissions

+ Strong negotiation skills and written/oral communication skills

+ Strong organizational skills and time management skills

+ Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines

+ Ability to work independently and under general direction only

+ Computer skills; MS Office, MS Project, Adobe Acrobat and Agile


**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.
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