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Post Market Surveillance Manager

4 months ago

Bengaluru, India Intuitive Surgical Full time
Company DescriptionAt 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

Leadership 

  • Provide leadership of the post market surveillance activities conducted by the India team.  
  • Conduct 1:1 and performance review meetings and responsible for PMS team training and development. 
  • Provide on-site leadership for other quality system areas e.g., CAPA, Advanced Failure analysis, Documentation, as directed.   
  • Provide direction and feedback to ensure compliance to Intuitive processes and procedures, and completeness and consistency of complaint investigation documentation. 
  • Manage complaint investigation workload to meet required operational goals. 
  • Execute QS and PMS projects and perform other duties as directed. 
  • Represent India Quality & Post market surveillance team at internal and external quality meetings. 

Technical 

  • Evaluate investigation documentation for completeness, accuracy, and consistency and provide feedback to team members where necessary to ensure adequate complaint investigations.  
  • Maintain accurate records and operational metrics of post -market surveillance activities and ensure compliance with regulatory requirements. 
  • Collaborate with senior PMS and Quality leadership and other internal teams (e.g., Advanced Failure Analysis Engineering, Clinical Development, Software Engineering, etc.) as needed. 
  • Serve as SME and on-site lead for PMS and Quality internal and external audits. 
  • Stay up to date on industry trends and India quality and post market surveillance regulatory changes. 
  • Strong understanding of worldwide regulatory requirements for medical devices, including post market surveillance, complaint handling, CAPA, Field Actions. 
Qualifications
  • Minimum of 8 years related work experience with a university degree; or equivalent 
  • At least 5 Years in employee management experience, handling multiple internal teams & departments 
  • Strong experience and knowledge of Medical Device Complaint files and quality record documentation requirements and implementation 
  • Strong knowledge of FDA & global QS and PMS regulations and ISO standards 
  • Regulatory/Quality Management experience 
  • Strong project management skills and experience in continuous improvement methodologies are preferred. 
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: 10% of the time