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Associate Regulatory Affairs Specialist

3 months ago

GondrecourtleChâteau, 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 many of the other therapies being developed in Cardiovascular are based upon.

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 Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for Cardiac Surgery products. Emphasis is on the post market sustaining activities which includes maintaining regulatory approvals, assessment of device changes for registration implications and support in geo expansions registrations.

A Day in The Life

  • Contributes to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files and Global Submission Summary Document.
  • Participates in preparation for and during internal and external regulatory audits
  • Compiles materials required for new global product submissions, license renewals and change submissions.
  • Monitors and improves global regulatory tracking/control systems
  • Request, obtain and maintain FDA CFGs including notarization and legalization, EC/ISO certificates and various other regulatory documents.
  • Participate in investigative activities such as CAPAs and non-conforming product
  • Perform other regulatory affairs duties when requested

Must Have: Minimum Requirements

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

  • Bachelor's degree required with 0 years of regulatory affairs or related experience

Nice to Have

  • Bachelors Degree in health profession, science and/or engineering field
  • Experience in medical device Industry
  • Demonstrated technical writing skills.
  • Strong computer skills, including word processing, spreadsheets and slide presentations
  • Excellent organizational skills
  • Strong written, verbal and interpersonal 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

56800

Max Salary

85200

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.