Compliance Specialist 3

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 primary function of this position is to coordinate and assist field action strategy team related activities. They are to possess an effective understanding of the field action process. They responsible in making sure the field action are executed in a timely manner by collecting all the necessary information needed to execute. The analyst will work closely with cross functional teams to ensure that execution of the field action is complaint and is within approved processes. On top of managing day to day activities for executing field actions, the analyst will also assist in providing historical field action data for requests coming in to the field action team. The analyst will also be expected to assist the team in record retention based on company and regulatory standards. If needed, the analyst will also act as a field action subject matter expert to provide guidance to other teams.

Roles & Responsibilities:

• Assist with the Product Correction and Removal process
• Provide applicable data for field removals, field upgrades, tracking of customer notifications, field service repairs, and maintenance of correction documentation.
• Conduct Global Field Action assessments (product return, status with competent authorities) for world-wide field actions
• Support group meetings to review open tasks, provide updates, and ensure that all tasks have been assigned
• Compile and maintain recall related paper and electronic records
• Assist in recall reporting and assist in the timely initiation and communication of recalls
• Support internal and external audits for recalls as established necessary by management.
• Provide manufacturing and product development with the necessary information to assess relative to product quality
• Assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.e. 21CFR 806 & part 7, CMDR, MEDDEV 2.12-1, etc.)
• Create and review ECO's as needed
• Prepare PIR summaries and reports for presentation to the PIR forum for review and maintaining documentation in accordance with department policies, procedures and work instructions
• Compile, monitor, and report on trending of pertinent metrics, as required
• Drive meetings for progress updates with global teams
• Manage kick off meetings (FAST) for new field actions
• Create customer response letters upon request
• Participate in new hire training and continuous Regulatory Compliance training as required
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Create and submit formal field action report for FDA, Health Canada, and distributors.
• Including monthly reports and closure requests.
• Assist in the backroom during audits and prep folders
• Maintain audit ready resources (field action binders)
• Manage the DVKB system and Trackwise
• Track, reconcile, follow up, and file RMA returns and acknowledgements from customer sites
• Work on legal request provided related to Field Actions

Qualifications

Skills, Experience, Education, & Training:

• Bachelor’s Degree
• 4+ years of experience in medical device field, with experience in the following areas:
• Knowledge and understanding with Medical Device field actions and quality record documentation
• Knowledge and understanding of Regulatory reporting requirements for Medical Devices in the field action space (US FDA requirements, EU MDD requirements, etc.)
• Self-guided and lead with limited assistance needed for executing field actions from beginning to end
• Demonstrate proven written and verbal communication skills
• Effective computer skills (Excel, Word, PowerPoint, database)
• Efficient autonomous worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload autonomously
• Prioritize numerous activities in a rapid paced environment
• Contribute to team oriented tasks
• Proven analytical skills
• Excellent interpersonal and decision making skills.
• Ability to maintain professionalism in all types of environments.
• Effective interpersonal and organizational skills with meticulous attention to detail.
• Must be able to work successfully within a team environment and autonomously

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.

Mandatory Notices

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:$116,900 - $168,200
Base Salary Range Region 2: $99,300 - $142,900
Shift: Day
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.