10 days old

Clinical Post Market Surveillance Manager - Adverse Events

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
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 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
Primary Function of Position:
The Clinical Post Market Surveillance Manager is responsible for monitoring and managing Post Market Surveillance staff handling of worldwide adverse event related complaint investigations and reporting. This role will manage a team of analysts and provide guidance, and feedback to ensure accuracy, consistency and compliance within the complaint and reporting processes. This position will drive process improvements for adverse event global reporting and complaint handling procedures as well as feed into and product improvements based on trends, regulation requirements, and a deep clinical understanding of the impact of Intuitive's products.

This role will be responsible to ensure proper analysis and escalation of events with clinically relevant information to the Senior Director of Post Market, Medical Safety Officer, Clinical Development Engineering and other applicable internal teams. Responsible for the maintenance of procedures and job aides related to Post Market Surveillance and Complaint Handling process requirements and ensure compliance with global regulations.

Roles and Responsibilities:

  • Day to day management of adverse event complaint investigations, regulatory reporting and a focused team of analysts supporting the Post Market Surveillance processes around complaint investigation and regulatory reporting:
  • Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events
  • Adherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirements
  • Guide team to consistently investigate and write, review, and file Medical Device Reports (MDRs)
  • Define and assess trends and alert limits or process triggers of safety concerns and define the escalation path to communicate these concerns.
  • Provide the risk management team required data to support and incorporate new failure modes into risk management files
  • Collaborate with the Medical Safety Office to define monitoring activities and ensure timely escalations.
  • Define and ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillance
  • Assess product relationship to reported complaints to root cause
  • Assure standard regulatory reporting assessment criteria
  • Provide input to clinical conclusion to be included in the complaint file and regulatory reports
  • Complete responses for Regulatory Agency Requests for additional information
  • Represent Post Market Surveillance at selected cross functional meetings
  • Assist in the organization and provision of complaint data for the Product Investigation Report process
  • Analyze complaint data to identify trends, issues or systemic discrepancies
  • Manage, coach and develop team of analysts driven to follow complaint handling industry best practices and continuous improvement activities
  • Provide monthly, daily, weekly reporting of key metrics and develop action plans when targets /goals are not met Drive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
  • Participate in internal and external audits
  • Analyze and provide complaint data reports for QRB and Management Review Meetings
  • Develop and maintain product knowledge of existing and new products
  • Work closely with the Quality leadership team to establish Quality Performance Metrics and Complaint Reports,
  • Provide data to support Corrective & Preventative Actions (CAPA) with particular emphasis on CAPAs escalated from Complaints
  • Perform reportability determinations in conjunction with medical safety officer, as necessary
  • Maintain awareness of new or revised regulations and/or guidelines
Skill/Job Requirements:
  • Bachelor's degree in health science, nursing or similar healthcare-related field, a Master of Science in Nursing desired, MD, or PhD degree is desired.
  • Minimum 6+ years of leadership experience in the medical device industry or direct device clinical experience related to applying regulations in a post market setting
  • Experience supervising others
  • Excellent interpersonal and leadership skills
  • Demonstrated ability to lead cross-functional and cross-business teams
  • Experience in Regulatory Affairs, Quality Assurance a plus
  • Must have direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 820, etc.), CMDR, JPAL, Medical Devices Directive (93/42/EEC, 98/79/EC), and EU MDR.
  • Global regulatory experience for complaint handling and reporting
  • Experience interacting with the FDA, ISO, and Other Regulatory Authorities
  • Must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
  • Excellent communications and analytical skills
  • Knowledge of medical/surgical terminology. Familiarity of the hospital and operative environment.
  • Ability to work effectively in a fast paced and dynamic environment.
  • Strong written and verbal communication skills
Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

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 : None

Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Clinical Post Market Surveillance Manager - Adverse Events

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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