Regulatory Affairs Specialist
POSITION SUMMARY:
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
ESSENTIAL FUNCTIONS OF THE POSITION:
Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S, Japan, and Canada. Submission support may include but is not limited to: IDEs, PMA submissions and supplements or 510k for US, EU Technical Documentation, and/or Japan Shonin.
Support global regulatory post-market activities for the responsible geographies above, such as updating 510(k) letters to file, Technical Files and Design Dossiers on an annual basis, preparing and submitting product renewals, and annual/post-approval reports.
Support product marketing in additional geographies, as necessary, with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
Request Certificates to Foreign government and Free Sale Certificates as new products are approved
Obtain notarization and legalization of documents as required
Maintain, update and track open regulatory requests. Provide periodic status updates on open and closed requests
Review of product and manufacturing changes for compliance with applicable regulations (Change Control)
Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies
Maintain submission correspondence files and other regulatory files in a complete manner
Maintain regulatory files for product compliance
Perform other related duties as assigned in support of regulatory activities
Assist in interacting with reviewers from regulatory agencies on specific projects
Provide support during internal and external audits
Maintain current knowledge of worldwide regulatory requirements
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgement
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
Hybrid environment (with remote possibilities)
Travel responsibilities to AtriCure facilities for team functions and activities when needed
BASIC QUALIFICATIONS:
Bachelor’s degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry
Proficient on programs within Microsoft Office
Written and verbal communication skills
Problem solving and/or troubleshooting experience
PREFERRED QUALIFICATIONS:
Minimum of 2 years of experience in the medical device industry
Basic knowledge of U.S. and/or European/International regulations and standards
Strong understanding of documentation within a quality management system
Team oriented and able to effectively manage and prioritize multiple projects
General knowledge of medical terminology
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to pass pre-employment drug screen and background check
Occasional travel may be required
MN Hiring Range:
$85,000-104,000
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