Job Detail

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

The Manager Post Market Surveillance is primarily responsible for oversight of the Post Market Surveillance process for medical devices, including complaint assessment and evaluation, adverse event reporting to competent authorities and Field Safety Corrective Action implementation. Manages Post Market Surveillance team. Liaises with other entities to ensure aligned processes.

Roles and Responsibilities:

Main activities

• Leads Post Market Surveillance activities in Europe and other assigned geographies


• Ensures that reported complaints are timely and accurately reported into the Complaint Management System and evaluated.


• Ensures medical device vigilance reports are timely and accurately reported to European authorities and in line with corporate processes


• Leads Field Safety Corrective Action implementation in the EMEIA region, including all aspects of documentation, regulatory reporting, customer notification, effectiveness checks and closure


• Drives adherence to departmental metrics.


• Leads, trains and develops Post Market Surveillance team members, including but not limited to:
  
  
  
  • Establishing goals
  
  
  • Defining priorities of the team
  
  
  • Sharing and providing technical expertise to team members
  
  
  • Coaching, advising, developing and removing obstacles for the team
  
  


• Maintains a positive relationship with European regulatory bodies by interfacing, communicating, and coordinating with regulatory agencies on adverse events and inquiries.


• Leads complex projects to ensure continued compliance to regulation and continuous improvement

Additional activities

• Identify and lead process improvement efforts;


• Implement and 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;


• Other regulatory tasks and projects may be assigned as necessary;


• Provides training to group and departments when needed.


• Travel: up to 20%.

Required Knowledge, Skills, and Experience:

• At least 8+ 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)


• Excellent 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 associated with goals objectives definition / people development.


• 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