Sr. Regulatory Engineer
Intuitive Surgical - Sunnyvale, CA

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Job

:

Clinical / Regulatory

Primary Location

:

United States-California-Santa Clara County-Sunnyvale

Schedule

:

Full-time

Sr. Regulatory Engineer

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120466

Description

Primary Function of Position:
New Product/Indication Submissions

Provide leadership to development, new product introduction, and manufacturing teams for assessing the impact of design inputs and outputs on regulatory filings and compliance. Create awareness within the organization regarding the international and domestic regulation and the product specific standards. Additional responsibilities include maintaining regulatory filings and licenses, and interacting with regulatory agencies during inspections.

Roles and Responsibilities:
Prepare and submit 510(k)s (FDA) to obtain regulatory clearances for new products, new indications, and significant product changes in a timely manner

Prepare “Memo to File” reports to support internal filings for product development projects and product changes

Provide oversight and assistance to product development teams for completion of Technical Files for Europe (CE Mark)

Prepare and submit notifications to European and Canadian regulatory bodies for new products and changes to existing products

Support product development teams on regulatory issues, including review of documentation

Provide leadership on documentation issues and mentor teams on requirements

Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required

Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process

Work directly with regulatory agencies on regulatory issues and submissions.

Perform other duties as required

Qualifications

Skill/Job Requirements:
Education:
B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering

Experience:
8 years relevant experience working in a medical device company

4 years of experience in submissions and technical documentation for a medical device company

Experience with new product development projects for complex products

Skills

Ability to create 510(k), memo-to-files, and technical documentation from scratch for complex new products

Experience in verification and validation methods and documentation

Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization

Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions

Good interpersonal skills and able to work well with cross-functional teams

Good project management skills

Intuitive Surgical - 14 months ago - save job - copy to clipboard
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Intuitive Surgical is haptic to meet you. Employing haptics (the science of computer-aided touch sensitivity), the firm developed the da...