Regulatory Affairs Specialist 3

Intuitive•Sunnyvale, CA

About The Position

Serve as the primary regulatory representative on project and product core teams. The Regulatory Affairs Specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products.

Requirements

Ability to work in a fast-paced environment and handle multiple projects simultaneously.
Ability to author and manage US FDA and Canada submissions and review processes.
Understanding of design controls with experience in verification and validation methods and documentation and their relevancy to regulatory assessments
Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.
Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
Ability to digest and convey information to project teams from regulators including regulations, guidance documents, and standards.
Ability to review and provide critical feedback on design documentation.
Ability to learn internal procedures and processes and implement on project teams.
Good interpersonal skills and ability to work well with cross-functional teams.
Good project management skills.
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)

Nice To Haves

RAPS - RAC Certification is a plus

Responsibilities

Develop regulatory pathway for US FDA and Canada new product registration, support product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements.
Assess the impact of the product and process changes, determine regulatory pathways for US and Canada markets, and prepare the corresponding regulatory submission or internal documentation.
Author regulatory submissions for US FDA 510(k) premarket notifications, internal “Letters to File” and Health Canada registration, and lead the review process through clearance/approval, where applicable.
Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approvals.
Create and maintain product summary technical file (STED).
Identify and convey requirements from applicable standards and guidance documents to project teams.
Provide leadership on documentation issues and mentor teams on requirements.
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 activities upon request.
Perform other duties as required.