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 leading company in the field of 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:
The Post Market Surveillance Sr. Supervisor supports the Regulatory Department by supervising the team responsible for post market surveillance, maintaining, updating and reporting departmental metrics and approving potentially reportable complaints. The Sr. Supervisor leads, trains and develops the team members, and acts as an expert in complaint/vigilance investigation reporting.
Roles and Responsibilities:
- Distribute vigilance reports and Regulatory Additional Information (RAI) Requests
- Supervise the team responsible for post -market surveillance to ensure that vigilance reports and RAIs are timely and accurately submitted, investigation is completed and the decision regarding regulatory reporting is appropriately documented
- Maintain, update and report departmental metrics (EU monitoring, KPIs)
- Approve vigilance reports and RAIs
- Draft vigilance reports and RAIs as appropriate to support the team when necessary
- Prepare and send monitoring reports
- Act as an expert in complaint investigation/vigilance reporting:
- Evaluate documentation for completeness and consistency and assign additional actions as necessary
- Perform the assessment review and approve the records
- Assist with customer escalations as needed and provide training to internal and external stakeholders
- Support compliance of post-market surveillance processes to EU MDR and other evolving regulatory requirements
- Developing and executing training programs to educate company personnel on post-market surveillance processes as needed
- Cross-collaborate with other departments as necessary (e.g. US PMS Team, Engineering Team, Customer Service, Regulatory Affairs, intra-company distributors etc.)
- Prepare and send monitoring reports as required
- Act as a PMS Subject Matter Expert during site’s audits/ inspection as necessary
People Management
- Lead, train and develop team members
Additional activities
- Act as a PMS Subject Matter Expert during site’s audits/ inspection as necessary
- Lead Improvements projects and drive them to completion as necessary
Qualifications
Required Knowledge, Skills, and Experience:
- In-depth knowledge and understanding of the European Medical Device Directive 93/43/EEC, MEDDEV 2.12-1 and EU Medical Device Regulation EU/2017/745 and MedDO SR 812. 213
- In-depth knowledge of quality records requirements and how they apply to complaint files and post market surveillance reports.
- A Bachelor’s degree or Swiss CFC (Health sciences preferred)
- 3-5 years of experience in Post Market Surveillance for medical devices
- Ability to handle multiple tasks, to prioritize and schedule work to meet business needs
- Demonstrate organizational and planning skills, including action oriented; focus urgency and driving for results.
- Good problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
- Demonstrate good communication skills, over the phone, in person and in writing.
- Demonstrate good interpersonal and leadership skills, ability to work with others in international team environment, effective interactions in cross department teams.
- Orientation for work result details, with emphasis on accuracy and completeness
- Fluent (C1 minimum) in written and spoken English
- General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
Preferred Knowledge, Skills, and Experience:
- 3 – 5 years of experience in a Medical Device environment
- US FDA 21 CFR 803/806/820 knowledge would be a plus.
- Experience with softwares such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus.
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.
