Senior Regulatory Affairs Specialist

New Product/Indication Submissions

Provide leadership to development new product introduction and manufacturing teams for assessing the impact of clinical strategy and design inputs and outputs on regulatory filings and compliance.  Create awareness within the organization 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 510(k)s and IDEs for new products new indications and significant product changes in a timely manner.
• Support clinical study strategy and design as it relates to supporting Regulatory filings.
• 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 leadership on documentation issues and mentor teams on regulatory requirements
• Support continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
• Work directly 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 in Engineering Sr. Regulatory Engineer or in a Science field (preferable) Sr. Regulatory Specialist
• Experience:
  • Minimum 5 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
  • 4 years of experience in submissions and technical documentation for medical devices (can be in combination with a regulatory degree e.g. Masters in Regulatory Science plus 3 years) and/or applicable work for a regulatory agency (2 years minimum)
  • Experience with new product development projects for complex products
• Skills:
  • Ability to efficiently and effectively create FDA submissions memotofiles and technical documentation for complex new products
  • Good understanding of design controls with experience in verification and validation methods and documentation
  • Able to work effectively and adapt in a dynamic early start uplike environment
  • Understanding of thirdparty test requirements such as UL / IEC product testing biocompatibility testing sterilization
  • verbal and written communication skills proven ability to translate technical documentation into effective regulatory submissions
  • Interpersonal skills and able to work well with crossfunctional teams
  • Proven 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 COVID19.  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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime