Regulatory Affairs Specialist, NPD

Job Description

 

New Product/Indication Submissions
Provide regulatory insight 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 team regarding international and domestic
regulations and product specific standards. Additional responsibilities include
maintaining regulatory filings and licenses, and interacting with regulatory agencies
during inspections.

Roles and Responsibilities:
• Prepare and submit sections of or complete 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” documentation to support internal filings for product
development projects and product changes not requiring regulatory agency
approvals.
• Support product development teams on regulatory issues, including review of
documentation.
• Provide insight on documentation issues and guide teams on regulatory
requirements
• Support continuous improvement of the submission process in accordance with
Intuitive Surgical Product Development Process.
• Work indirectly or directly or with regulatory agencies on regulatory issues and
submissions.
• Support international regulatory efforts as needed.
• Perform other duties as required.

Qualifications

Skill/Job Requirements:

• Education:
  • B.S. or higher, preferably in Engineering or in a Science field
• Experience:
  • Minimum 3 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science) and/or applicable work for a regulatory agency
  • Minimum 2 years of experience in submissions and technical documentation for medical devices
  • Experience with new product development projects for complex products
• Skills:
  • Ability to create 510(k) submissions, memo-to-files, and technical documentation for complex new products
  • Understanding of design controls with 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

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.