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.
Primary Function of Position:
The Senior Regulatory Compliance Program Manager for Product Issue Escalation-Recalls/Management Review will provide leadership for ISI’s quality systems function to ensure the overall quality management system (QMS) align with domestic and global regulatory requirements. Collaboration with business partners and management will be key to create and sustain a QMS infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. The Staff level person will have strong leadership skills to support established customer-focused quality initiatives plus technical product understanding to support continuous improvement and enable safety. The leadership skills will serve to manage projects that identify and drive continuous improvements for a robust and agile QMS.
Roles & Responsibilities:
- Responsible for coordinate planning, scheduling, logistics and conducting product issue escalation meetings - recalls. Provides guidance to SMEs for meeting requirements. Works with Engineering, Quality and Operations teams as needed to ensure the information needed for the meeting is available.
- Provides guidance to stakeholders in the interpretation of FDA regulations and external regulations/standards pertaining to assessing the need for field actions.
- Responsible for documenting, tracking and obtaining approval and archival of the product issue escalation meeting , including attendance, meeting minutes, action items, and final decision.
- Responsible for coordinate planning, scheduling, logistics and preparation for regional and executive Management Reviews, documenting, tracking and closing Action Items
- Responsible for obtaining approval and archival of Management Review, including attendance, meeting minutes, action items etc.
- Provides leadership for Quality Systems and Compliance projects and personnel to ensure the fulfillment of company quality goals and objectives
- Mentors others for the development and maintenance of a robust quality systems and compliance team
- Support facility inspections and audits required by government and regulatory agencies on a global basis.
- Works with Audit Management on maintaining audit readiness for internal and external audits; provides backroom leadership during external audits
- Performs assessments, develops action plans, and drives/facilitates implementation activities to address new requirements from global standards or regulations
- Supports business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed
- Develops, maintains and improves processes and procedures for various processes within the quality management system and where necessary, provides training
- Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate, leads primary quality initiatives within the quality systems
Skills, Experience, Education, & Training:
- Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field
- Minimum Ten plus (10+) years’ experience in quality systems, quality engineering, or compliance (or combined experience) in the medical device or other regulated industry
- 1-2 years direct experience in field actions/recalls in Medical Device Industry is strongly preferred.
- Five plus (5+) years’ experience in a leadership role with direct management experience strongly preferred
- Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects
- Applied understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR – Canada, European, RDC – Brazil)
- Experience with computer software validation (CSV) regulations/standards and methodologies
- Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization; and providing training
- Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficient in constructive dialogue
- Effective at prioritizing of tasks and responsibilities within a fast-paced, dynamic environment
- Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness
- Good understanding of failure analysis and product investigations; application of risk management with respect to post-market surveillance.
- Practiced in presenting to various levels of management
- Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred)
- Applied knowledge of validation methodologies pertaining to computer system, process and equipment (preferred)
- Six Sigma Greenbelt certification or other professional certification (e.g., ASQ certification) (preferred)
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.
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: $155,000 - $223,000
Base Salary Range Region 2: $131,800 - $189,600
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.