Regulatory Affairs Specialist

Primary Function of Position:

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.
• Prepare and maintain Technical Files for Europe (CE Mark) for new products, new indications, and significant product changes in a timely manner.
• 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.

Skill/Job Requirements:

• Education:
  • Minimum B.S. or higher in Engineering [Regulatory Engineer] or in a Science field (preferable) [Regulatory Specialist]
• 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
  • Excellent 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

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 Employment 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.

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

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.

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 Employment Opportunity / Affirmative Action 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.

EEO and AA Policy

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.