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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