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:
Senior Manager, Product Compliance and Escalations will provide oversight, expertise, and support to ensure on-going compliance with domestic and international regulations and standards. S/he will work with cross functional organizations (Quality Systems, Product Quality, Risk Management, Clinical, Post Market, Service, Customer support etc.) as the Compliance representative and support product issues/escalations, triaging the issues, review of product investigations, understanding impact to the field and oversee any associated field corrections and removals. S/he will ensure overall Quality Management System (QMS) compliance to internal process/procedures as well as regulatory requirements/standards and ensure understanding of applicable laws and regulations so that the company’s risks are identified and managed appropriately.
Roles & Responsibilities:
- Compliance representative on escalation meetings, to understand the product/process issue, risk, clinical impact and help establish escalation decisions/conclusions.
- Support Product Investigations, help with determination of field impact, and any associated field actions, corrections and/or removals.
- Oversee field action strategy, execution and implementation based on understanding of product technical issue, clinical/product/user risk, and actions to be taken with the product in the field.
- Help author and review field action and customer letters/communication to ensure the documentation aligns with the overall strategy and meets the regulatory/compliance requirements.
- Help author and review any follow-up questions, responses related to the field actions.
- Help provide guidance on a variety of ad-hoc product/compliance questions, including helping research the regulations, current process/practices within ISI, industry/regulatory agency expectations etc.
- Provide guidance, review and approve various documents on behalf of Reg. Compliance, ranging from EDFs, PIRs, customer facing materials, technical bulletins, QS procedures.
- Participate in process improvements, streamlining and scalability associated with above processes.
- Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies.
- Support the Quality System and Compliance (QSC) team overall, as needed, related to QRB/Management Review, Audits, Facility Changes, CAPAs, Process improvements etc.
Qualifications
Skills, Experience, Education, & Training:
- 10+ years of experience in a Quality role in the medical device industry is required.
- 4+ years’ experience as a people lead/manager
- Bachelor’s Degree in an engineering, scientific or other relevant field is required. Master’s Degree in engineering or scientific field preferred.
- Demonstrated ability to understand complex technical issues and direct experience working with surgical medical devices/instrumentation (US: Class II and III) in (any) area of Capital Equipment, Software, Wireless technology, Disposable/Reusable instrumentation and/or implantable devices
- Demonstrated experience/exposure to aspects of Medical Device Design Control and/or Production/Process Controls, and/or Corrective/Preventive Actions and/or Corrections/Removals
- Demonstrated ability to work in highly cross-functional teams, including direct experience working with engineering, clinical and risk management functions.
- Demonstrated ability to effectively manage teams/direct reports, provide guidance, make decisions, and manage growth
- Applied understanding of US FDA Quality System Regulations, ISO 13485, ISO 14971
- Ability to be a team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use risk based judgment.
- Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology
- Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
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 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.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
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 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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $176,000 USD - $264,000 USD
Base Salary Range Region 2: $149,600 USD - $224,400 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
