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Regulatory Affairs Manager - Cardiac Rhythm and Heart Failure Diagnostic

Medtronic
Mounds View, MN 55112
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Regulatory Affairs Manager - Cardiac Rhythm and Heart Failure Diagnostic

Location:

Mounds View, Minnesota, United States

Requisition #:

20000E0U

Post Date:

Sep 10, 2020


**Regulatory Affairs Manager- Cardiac Rhythm and Heart Failure Diagnostic**


The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one 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. This group includes Aortic and Peripheral Vascular (APV), Cardiac Rhythm and Heart Failure (CRHF), and Coronary and Structural Heart products.


The **Cardiac Rhythm and Heart Failure (CHRF)** Group provides bradyarrhythmia management products, cardiac ablation products, cardiac mapping, cardiac diagnostics and monitoring, heart failure management, and tachyarrhythmia management products.


The **Regulatory Affairs Manager** is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for submission activities focused on US/EU and for ensuring regulatory compliance. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs. Collaborate with International RA, RD, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle. Manages department activities with responsibility for results in terms of costs, methods and employees. Accomplishes results through hands on and delegation of responsibility to individual contributors. Provides leadership, coaching and career development.


**A Day In The Life**


+ Provides direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.

+ Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products.

+ Participate on Product Development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.

+ Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.

+ Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.

+ Drive product change assessments and define regulatory impact of product changes in global markets.

+ Review and approve labeling, training, promotional, and advertising material.

+ Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, and international requirements.

+ Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.

+ Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.

+ Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, issue assessment).

+ Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.

+ Provide targeted career coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.

+ Conduct timely and candid performance evaluations. Support meaningful development activities.


**Must Have: Minimum Requirements (Must be evident on the resume)**


+ Bachelor's Degree required. Engineering or Advanced degree desired.

+ Minimum 5 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility

+ Or an advanced degree with minimum 3 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility


**Nice To Have**


+ Engineering degree.

+ Advanced degree.

+ 3+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity

+ Excellent knowledge of U.S. and European/International regulations and standards

+ Experience interacting with FDA and/or other regulatory agencies

+ Proven ability to prioritize, conduct, and manage time to meet project deadlines

+ Must work well in dynamic and cross functional team environments

+ Must demonstrate collaboration and leadership skills in team setting

+ Proven analytical abilities

+ Solid understanding of manufacturing and change control, and an awareness of regulatory trends

+ Understanding of engineering concepts and scientific terminology

+ Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales

+ Experience reviewing design specifications and other technical documents

+ Superior interpersonal skills

+ Excellent communication skills, both oral and written

+ Documented evidence of writing skills

+ Basic understanding of computer applications; proficient in Microsoft Office Applications

+ Familiarity with medical terminology

+ Some overnight travel required


**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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Posted: 2020-09-15 Expires: 2020-10-23
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Regulatory Affairs Manager - Cardiac Rhythm and Heart Failure Diagnostic

Medtronic
Mounds View, MN 55112

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