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Regulatory Co-op – Spring 2022
Mason, OH, USA
Req #575
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
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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.