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Regulatory Co-op - Spring 2022 Job in Mason, Ohio US

Regulatory Co-op - Spring 2022

Atricure, Inc. - Mason, OH

Posted: 9/23/2021 - Expires: 12/22/2021

Job ID: 232044864

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Job Description

Regulatory Co-op - Spring 2022

Mason, OH, USA
Req #575

Thursday, September 23, 2021


As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator Synergy Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients' worldwide.

Position Summary:

The Regulatory Affairs Co-Op is intended to support the Regulatory team by assisting with day to day tasks and regulatory submissions to the FDA. The Co-Op will be responsible for helping with the organization of documentation and  other carious tasks for the department. In addition to calendar management, the individual may perform duties such as coordination of meetings, filing expense reports, and working on special projects. This role may require handling of highly confidential and sensitive information.

Roles and Responsibilities:

Assists with preparation of 510(k)'s, PMA's, and other regulatory submissions
Provides support and documentation to international partners in support of international registrations of medical devices
Maintains the Regulatory budget, process check requests, and initiate purchase orders
Scans, archives, and sends regulatory documents as directed
Maintains internal documentation of domestic and international regulatory approvals
Creates, edits, and develops visual presentations as needed
Attends team meetings and other project meetings as necessary
Completes other tasks and projects as assigned by members of the Regulatory department

BASIC QUALIFICATIONS:

High School Diploma or Equivalent
Pursuing a Bachelor's Degree in Biomedical or Chemical Engineering, Business or a Science
Have a strong interest in Regulatory Affairs at a Medical Device company
Computer/data entry Skills
Verbal Communication Skills
Proficient in Microsoft Office
Strong Organizational Skills

PREFERRED QUALIFICATIONS:

Team oriented
Able to effectively manage and prioritize multiple projects

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement - i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):

Regulatory walk, sit, and stand
Occasionally bend and push/pull
Occasionally lift over 25 pounds
5% travel potential
Position dependent upon candidate passing pre-employment physical/drug screen

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet
Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits

AtriCure participates in the federal E-Verify program to confirm the identity of and employment
authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/

AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

Job Family
Co-op/Intern

Job Function
Research & Development

Pay Type
Hourly

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
High school graduate
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
59846525
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A