Sr EU Clinical Quality Assurance Analyst

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Job Description

Primary Function of Position:

Responsible for day-to-day case management of serious adverse event (SAE)/adverse event (AE), device deficiency (DD) (and other potentially reportable) records. Performs regulatory reporting following events identified during pre and post market clinical investigations/studies performed on European (including United Kingdom (UK) and Switzerland) markets by or on behalf of Intuitive Surgical. Prepares responses regarding safety reporting to relevant National Competent Authorities (NCAs), Ethics Committees (ECs) and internal stakeholders.

This position will assess incoming communication to identify potential SAEs/AEs, DDs, and other reportable event types, and follow-up with the associated sites/internal stakeholders for additional information. This role is responsible for regulatory reporting in compliance with local and international regulations, guidelines, and applicable directives.

Roles and Responsibilities:

• Record, assess and process all SAEs/AEs, DDs, and other reportable event types (as applicable) notified by Intuitive Surgical’s Clinical Affairs and/or associated internal/external site contact(s). Evaluate documentation during reconciliation and for individual events, ensuring completeness and consistency. Perform additional actions as necessary to complete processing of event records.
• Liaise with the Clinical Affairs team to ensure that clinical documentation/processes/study databases are aligned with standards and regulations per pre and post market expectations with regards to safety reporting for each country in which the study is carried out.
• Act as a liaison for the organization to lead trainings, provide guidance and feedback about processes and interacting workflows.
• Represent the Clinical Reporting team in cross functional meetings as required.
• Contact sites and internal stakeholders as appropriate to obtain key relevant data for case management.
• Prepare and submit reports and responses to requests for additional information to the proper regulatory authority within the required reporting period.
• Notify any device falsification and/or serious health impact events as appropriate to internal European and Swiss Authorized Representatives, UK Responsible Person as well as Persons Responsible for Regulatory Compliance.
• Provide support for internal audits and external inspections related to Clinical reporting.
• Identify and escalate any issues identified to the appropriate internal stakeholders before they become critical.
• Define metrics with internal stakeholders demonstrating compliance and performance of the activity.
• Lead process improvement activities related to effectiveness and timeliness with management support.
• Analyze and trend data to identify new issues or systemic discrepancies as necessary.
• Identify and assess regulatory requirements/reportability for new clinical investigations/studies with cross functional team members.
• Perform quarterly and annual safety reporting. Conducts review/ trending of events and provides feedback to Clinical Reporting and Clinical Affairs teams.
• Review and approve team’s reports when required.
• Other regulatory tasks and projects may be assigned as necessary.

Qualifications

Required Knowledge, Skills, and Experience:

• Associate’s, Bachelor’s or Master’s degree in Biomedical Engineering, Life Science (or equivalent).
• 3+ years of experience in clinical studies or regulatory reporting (pre and/or post market; preferably for medical devices).
• Knowledge and understanding of regulatory reporting requirements for medical devices (MDD, EU MDR, US FDA requirements, local regulations/guidance documents, etc.).
• Ability to handle and manage workload independently.
• Demonstrates leadership ability and offers guidance/ oversight to others within the team and organization.
• Fluent (C1 minimum) in written and spoken English (business language used). Preferred: French and/or German at B2 level.
• General computer literacy (Microsoft Office, etc.). Preferred: experience with TrackWise, CRM/SAP software.
• Preferred: Working knowledge of clinical terminology, medical conditions, and biological systems.

Additional Information

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.

Shift: Day
Travel: None