Senior Regulatory Affairs Specialist

2 weeks ago


GondrecourtleChâteau, Grand Est, United States Medtronic Full time
Senior Regulatory Affairs Specialist - Cardiac Surgery (hybrid)

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
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.

Careers that Change Lives
The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and EU submissions and maintaining approval for products.

Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.


A Day in the Life / Responsibilities:
Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products.


Team with operating unit Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support changes to existing products.

Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

Prepare regulatory (e.g., FDA/Notified Body) submissions for product changes, as required, to ensure timely approvals for market release.

Review significant product submissions with manager and negotiate submission issues with agency personnel.

Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.


Provide business and product information to international regulatory team to enable development of strategies and requirements and communicate that information to business teams.

Ensure personal understanding of all quality policy/system items that are personally applicable.

Follow all work/quality procedures to ensure quality system compliance and high-quality work.

Must Have:
Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelors degree required

Minimum of 4 years of experience in regulatory affairs in the medical device industry

Or advanced degree with a minimum of 2 years of experience in regulatory affairs in the medical device industry.

Nice to Have (Preferred Qualifications):
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).

Proficiency in assessing changes to labeling, design, materials and manufacturing for impact to US and EU requirements

Experience with 510(k)/IDE/PMA device product submissions and EU regulations (MDR)

Experience with FDA and international regulatory agency requirements

Effective interpersonal skills and team member.

Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

Ability to effectively manage multiple projects and priorities.

Proficient computer skills.

Project management skills.

Excellent oral and written skills.

Excellent analytical thinking skills.

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, recruiter 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 here ) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Min Salary
88800
Max Salary
133200

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.

#J-18808-Ljbffr

  • Gondrecourt-le-Château, Grand Est, United States Axelon Full time

    Job Title: Exciting Opportunity as a Senior Regulatory Affairs Specialist at a Leading CompanyLocation: St Paul, MNWorking Hours: 8:00 a.m - 5:00 p.m.About the Role:Collaborate with various business units to enhance and streamline regulatory processes.Aid in executing strategies for regulatory affairs, overseeing product registration submissions, reports,...


  • Gondrecourt-le-Château, Grand Est, United States Medtronic Full time

    Associate Regulatory Affairs Specialist (hybrid) Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains extremely important in treating complex disease and remains the gold standard on which...


  • Gondrecourt-le-Château, Grand Est, United States Medtronic Full time

    Associate Regulatory Affairs Specialist (hybrid)Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains extremely important in treating complex disease and remains the gold standard on which...


  • Gondrecourt-le-Château, Grand Est, United States STERIS Full time

    At STERIS, we are dedicated to helping our Customers around the world build a healthier and safer environment through our innovative healthcare and life science solutions.Job Title: Senior Regulatory Affairs ManagerCompany: STERISPosition Summary:The Regulatory Affairs team at STERIS plays a vital role in obtaining and retaining product registrations to...


  • Gondrecourt-le-Château, Grand Est, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Regulatory Specialist II, Electrophysiology Pulsed Field Ablation, Regulatory Affairs At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting...

  • Regulatory Specialist

    2 weeks ago


    Gondrecourt-le-Château, Grand Est, United States Bell International Laboratories Full time

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements. Make sure...


  • Gondrecourt-le-Château, Grand Est, United States Boston Scientific Full time

    Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Gondrecourt-le-Château, Grand Est, United States Ecolab Full time

    Pharma and Personal Care - Regulatory Affairs Manager/ NA Regulatory Business Partner At Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries. Ecolab is a company committed to growth and we believe...


  • Gondrecourt-le-Château, Grand Est, United States Collabera Full time

    Home Search Jobs Job Description Regulatory Document Coordinator Contract: St. Paul , Minnesota, US Salary: $35.00 Per Hour Job Code: End Date: Days Left: 1 days, 3 hours left Apply Day to Day:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs,...


  • Gondrecourt-le-Château, Grand Est, United States Kerecis Limited Full time

    SummaryThe Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-time role reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is located in the Minneapolis,...

  • Senior EHS Specialist

    2 weeks ago


    Gondrecourt-le-Château, Grand Est, United States Ferring Pharmaceuticals Full time

    Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first'...

  • Senior Vice President

    2 weeks ago


    Gondrecourt-le-Château, Grand Est, United States Arc Initiatives Full time

    Job Description Job Description Salary: $125,000+About UsArc Initiatives is a full-service political, digital, and public affairs consulting firm. Our team consists of experienced professionals ranging from the highest level of national politics, including six presidential campaigns, to grassroots advocacy work and critical state and local races. Our ties to...


  • Gondrecourt-le-Château, Grand Est, United States IntePros Consulting Full time

    Sr Compliance Specialist Top 3 things the manager is looking for: Prior experience with CAPAs in Medical Device, preferably Medtronic Prior CAPA Owner or CAPA Specialist Process engineering i.e. Green/Black Belt work Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance...


  • Gondrecourt-le-Château, Grand Est, United States CommonBond Full time

    Home is the foundation for everything in life. Since 1971, our model has been about supporting residents in finding stability and achieving their goals. It's why we're more than housing-we combine quality affordable homes with our on-site Advantage Services-because we believe that with the right support and opportunities, all people can thrive. Today, over...

  • Grant Specialist

    2 weeks ago


    Gondrecourt-le-Château, Grand Est, United States Minnesota City Jobs Full time

    Come and be part of our team! The City of Saint Paul Office of Financial Services is looking to add a Grants Specialist to our crew. This role offers an exciting chance to engage in prospecting, writing, oversight, and coordination of grants citywide.What you'll be doing:- Assist senior staff in identifying grant opportunities- Review and communicate grant...


  • Gondrecourt-le-Château, Grand Est, United States The Fountain Group Full time

    Pay: $42-40 Currently seeking a EHS/Environmental Health & Safety Specialist for a premier leader in the Medical Device industry This is an onsite position in the greater Minneapolis region NOT a remote opportunity.As an Environmental Health and Safety Specialist you will support the plant by leading environmental compliance, occupational safety, and health...


  • Gondrecourt-le-Château, Grand Est, United States Ecolab Full time

    Coordinate with marketing to define the Institutional market test process, putting controls and procedures in place, and implementing them through testing. Lead market test efforts for Institutional innovation, proving customer value and providing v Account Specialist, Technical, Principal, Specialist, Technology, Support, Application


  • Gondrecourt-le-Château, Grand Est, United States U.S. Bank Full time

    At U.S. Bank, we are dedicated to striving for excellence every day. We assist our clients and partner businesses in making wise financial decisions while supporting the growth and success of the communities we serve. We believe that achieving our common goals requires the unique potential of each individual. A career at U.S. Bank provides you with a diverse...

  • Grant Specialist

    2 weeks ago


    Gondrecourt-le-Château, Grand Est, United States Minnesota Council of Nonprofits Full time

    Come join our team The City of Saint Paul Office of Financial Services is hiring a Grants Specialist. This is an exciting opportunity to provide prospecting, writing, oversight, and coordination of grants citywide.Heres what you can expect to do:Assists senior staff in identifying grant opportunitiesReviews and communicates grant guidelines, works with...


  • Gondrecourt-le-Château, Grand Est, United States Ecolab Full time

    The Senior/Principal Technical Account Specialist role will give you the benefit of forming close relationships with customers and the Corporate Account sales team, but it will also provide you an opportunity to take control of the Institutional Market Test Process and create controls and procedures to provide improvements. As part of this you will help...