Senior Regulatory Affairs Specialist
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
As a Senior Regulatory Affairs Specialist you will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. You will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory guidance on post-market product changes to maintain marketing approvals.
Every day you will have the opportunity to
- Prepare written regulatory strategies for new product development and sustaining projects
- Plan, coordinate and compile submissions and with sign-off responsibility
- Represent Regulatory Affairs as a core team member of new product development projects to drive innovation and to support Design Control process
- Act as the Regulatory liaison with key agency stakeholders including FDA, EU Notified Body, Health Canada, and other government agencies on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity product change on product registration and license globally
To thrive in this role you must have
- A Bachelor’s degree or equivalent combination of experience, education and training
- Ideally, 4+ years regulatory affairs work experience with a concentration in medical devices
- Strong understanding of U.S. and European/International regulations and standards
- Good technical writing skills as well as a strong communicator in a team setting
What we offerWith AtriCure, you'll get the opportunity to work with a team that is passionately dedicated to improving the lives of patients with Atrial Fibrillation worldwide. It is also a company that will invest in your professional development to help you grow and be successful in your role. When joining AtriCure your offer includes a competitive salary, medical/dental/vision insurance which starts on the first day of employment, 401K with company match, company performance-based bonus, ESPP, volunteer time-off, diverse learning opportunities, regular company events to celebrate holidays, and more! If you see yourself as a strategic Regulatory Affairs professional and love being part of a growing company that impacts the lives of others every day, we would like to talk with you.
- Job Family Regulatory Affairs
- Job Function Regulatory
- Pay Type Salary
- Employment Indicator Non Manager