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Regulatory Affairs Manager - Cardiac Surgery (remote)

Mounds View, MN 55112 Work Remotely
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Regulatory Affairs Manager - Cardiac Surgery (remote)


Mounds View, Minnesota, United States

Requisition #:


Post Date:

Mar 23, 2022


Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio.

Key technologies include:

Surgical heart valves

Cardiac OR solutions (e.g., blood management, cannulae)

Extracorporeal life support

Coronary artery bypass grafting (CABG) 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.

Preference is for this position to be based in Mounds View, MN; however a remote assignment may be considered.

**Careers That Change Lives**

The **Regulatory Affairs Manager** will report directly to the Director of Regulatory Affairs in Cardiac Surgery (CS) and is responsible for establishing strategy for worldwide product approval submission activities and maintaining global regulatory compliance for CS products. The Regulatory Affairs Manager is expected to accomplish results through managing and mentoring a team of RA specialists. This role will require collaboration with cross functional business partners to develop regulatory strategies in support of business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement.

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

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

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

+ Mentor RA specialists that participate on core teams, reviewing regulatory strategy and timelines.

+ Provide guidance and feedback to ensure high quality pre and post market submissions for global markets to support new product approvals and product renewals.

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

+ Collaborate with international RA partners to align on regulatory impact of product changes in global markets.

+ Review and approve promotional and advertising material.

+ Ensure product files are compliant 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.

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

+ Provide targeted career coaching and feedback; manage and develop team members at all levels of experience.

**Must Have: Minimum Requirements**

To be considered for this role, please ensure the minimum requirements are evident on your resume.

+ Bachelors Degree

+ Minimum of 5 years experience in regulatory affairs for medical device withroles showing increasing responsibility

+ OR advanced degree and a minimum 3 years experience in regulatory affairs for medical device with roles showing increasing responsibility

**Nice to Have (Preferred Qualifications)**

+ Engineering or Advanced degree desired.

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

+ Proven track record of leading high performing teams

+ Ability to recognize and develop key talent

+ Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products

+ Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions

+ 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 including ability to coach and develop team members, and effective resource management to address multiple priorities

+ Proven analytical abilities and utilization of system tools such as electronic document control systems

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

+ Understanding of engineering concepts and scientific terminology; experience with vascular therapies preferred

+ 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

+ RAPS certification (RAC)

**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 benefits:

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.


Posted: 2022-03-25 Expires: 2022-06-03
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Regulatory Affairs Manager - Cardiac Surgery (remote)

Mounds View, MN 55112

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