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Sr. Regulatory Engineer

Job Number: 70425691
Company Name:Intuitive Surgical
Location: Sunnyvale, CA US
Career Focus:Information Technology
 Updated: 4/25/2013

Sr. Regulatory Engineer
Title: Sr. Regulatory Engineer
Location: United States-California-Santa Clara County-Sunnyvale
Job Number:_120466
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


Job: Clinical / Regulatory

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