Supplier Quality Engineer NeuroPace
THIS JOB HAS EXPIRED Job Description:
Responsible for Regulatory Affairs support of product development projects and submissions for highly technical and complex active implantable medical device systems.
Provides regulatory support for highly technical and complex medical device systems.
As a core team member of manufacturing and product development teams, provides regulatory feedback and guidance throughout the product development cycle, and coordinates team inputs for submissions.
Develops and maintains positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of select submissions under review.
Project manages and prepares regulatory submissions for clinical investigations and marketing approval as well as internal file documentation with minimal supervision and support.
Reviews, and approves device labeling, promotional and advertising materials including making recommendations for appropriate changes to ensure compliance.
Reviews, makes recommendations for appropriate changes, and approves design control plans, and product and manufacturing changes.
Implements regulatory strategies for new and modified products.
Provides technical guidance and regulatory training/mentoring to cross-functional teams.
Develops and implements departmental policy and procedures.
Assists in establishing project priorities, allocating resources and workload.
Assists in the development of effective regulatory strategies for new and modified devices to assure timely regulatory approval in support of business goals and objectives.
Assists Clinical Affairs with the development of the most effective clinical trial strategies and protocols.
Bachelor's degree in a scientific or technical discipline required, advanced degree preferred.
Substantial Regulatory Affairs medical device industry experience required.
Ability to rapidly develop working understanding of highly technical and complex active implantable medical device systems required.
Extensive understanding of and experience with FDA regulations required. PMA experience required. Understanding of international regulations preferred.
Proficient knowledge of clinical trial strategy and study design with good working knowledge of statistical methods and data reporting.
Extensive experience in the preparation of regulatory submissions and documentation required, including highly developed written and oral communication, technical writing and editing skills and proficiency with Microsoft Office and Adobe.
Regulatory project management experience required, including excellent project and time management skills with an attention to detail and the ability to effectively manage multiple projects
Demonstrated proficiency at meeting deliverable deadlines required.
Thorough knowledge of product development process and design control, and an excellent grasp of change control and verification and validation requirements.
Excellent research and analytical skills.
Excellent organizational, interpersonal and influencing skills.
NeuroPace is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, 401(k), and stock options.
||1375 Shorebird Way |
Mountain View, CA 94043
THIS JOB HAS EXPIRED