EU Post Market Surveillance 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 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 Analyst supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting, identifying supporting data and notifying regulatory agencies as necessary.

Roles and Responsibilities:

Main activities:

• Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes;
• Works closely with Customer Service to support the product return process as it relates to complaints;
• Processes, records and closes complaint-handling activities in a timely manner;
• Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes;
• Determines reportability of complaints per regulatory reporting requirements;
• Collect, trend and escalate data related to Post Market Surveillance;
• Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors;
• Evaluates and reports device malfunctions and adverse events involving company products to the European regulatory agencies (20-40 % of the time);

Additional activities:

• Support Quality Management system activities such as CAPA, Field Safety Corrective Actions, documentation, training, management review and internal & external audits as needed;
• Ensures that company procedures, processes and documentation meet the required guidelines for maintaining compliance to the Quality Management System, ISO 13485 and other applicable regulations;
• Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes;
• Assists and supports other employees, teams and field personnel as necessary;
• Other regulatory tasks and projects may be assigned as necessary.

Qualifications

Required Knowledge, Skills, and Experience:

Knowledge:

• Good knowledge / understanding of the European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1;EU MDR 2017/745, MedDO SR 812.213
• Good understanding of quality records requirements and how they apply to complaint files and post market surveillance reports;
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).

Experience:

• A Bachelor’s degree or Swiss CFC (Health sciences preferred);
• 2 years of experience in Post Market Surveillance department in a regulated environment (e.g. Medical Device, Pharma, Aviation, etc.).

Interpersonal skills:

• 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;
• Demonstrate good communication skills, over the phone, in person and in writing;
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams;
• Ability to guide customers in providing key relevant data for case management;
• Ability to work autonomously, exercise daily judgment based on above regulatory knowledge;
• Orientation for work result details, with emphasis on accuracy and completeness;
• Fluent (C1 minimum) in written and spoken English.

Preferred Knowledge, skills and experience

• 2 – 5 years of experience in a regulated environment (e.g. Medical Device, Pharma, Aviation, etc.);
• US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) basic knowledge would be a plus;
• Ideally possessing other third language skills for the European market;
• Experience with softwares such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus.

Additional Information

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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.