EU Post-Market Surveillance Supervisor

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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.

Primary Function Of Position

The Supervisor Post Market Surveillance is responsible for day-to-day oversight of the Post Market Surveillance team assigned to complaint handling and vigilance reporting activities.

Roles And Responsibilities

Main activities

• Lead complaint handling and vigilance reporting:
• Supervises the team responsible for post-market surveillance to ensure that reported complaints are timely and accurately reported into the Complaint Management System, followed up on with customers to gather additional clinical and/or technical information as needed and that the decision regarding regulatory reporting is appropriately documented
• Ensures medical device vigilance reports are timely and accurately reported to European Authorities according to corporate processes.
• Maintains, updates and reports departmental metrics
• Act as an expert in complaint investigation and 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
• Support compliance of post-market surveillance processes to EU MDR and other evolving regulatory requirements
• Lead, train and develop team members, including but not limited to:
• Establishing goals and defining priorities of the team on a daily basis
• Sharing and providing technical expertise to team members,
• Provide leadership, guidance, and supervision to PMS team
• Developing and executing training programs to educate company personnel on post-market surveillance processes as needed.
  

Additional activities

• Write, review, and draft Vigilance Reports as required.
• Prepare responses to Regulatory Agency requests for additional information as required.
• Lead specific investigations and coordinate with other departments (i.e. R&D, Marketing, Field Service, Reprocessing Specialists, Clinical Affairs, etc.).
• Monitor effectiveness of established complaints processes and support continuous improvement of department procedures
• Support Quality Management system activities such as CAPA, Field Safety Corrective Actions, documentation, training, management review and business development activities as needed
• Act as a PMS Subject Matter Expert during site’s audits/ inspection
• Supports product quality holds or Field Safety Corrective Actions as necessary
• Other regulatory tasks and projects may be assigned as necessary
• Travel: up to 10%.
  

Required Knowledge, Skills, And Experience

• At least 5+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
• A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
• Strong knowledge of EU MDD 93/42/EEC, MEDDEV 2.12-1, EU MDR 2017/745/EU, ISO 13485:2016
• Strong experience in Post Market Surveillance according to EU requirements
• Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
• Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
• Orientation for work result details, with emphasis on accuracy and completeness
• Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams
• Team management experience of small team size
• Language: Fluent in written and spoken English
  

Preferred Knowledge, Skills, And Experience

• Experience of US FDA 21 CFR 803 (Medical Device Reporting) or 21 CFR 806 is a plus
• Language: ideally possessing other language skills for the European market
  

Shift : Shift 1 - Day

Travel : Yes, 10 % of the Time

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