Sr Regulatory Surveillance Analyst

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 Senior Regulatory Surveillance Analyst works closely with the RSM Manager and team to help RSA initialization, assessment and implementation of Standards and Regulations applicable to Intuitive. The Analyst reviews and approves Regulatory Surveillance Assessments and integration plans. The Analyst will also maintain process documentation and logs and generate metrics and other reports to help internalize global regulations and meet compliance targets for completion of Regulatory Surveillance Assessments and Integration Hand-off activities. The Analyst is accountable for executing activities associated with Intuitive's RSM Process and other company procedures to create and maintain records and logs for Regulatory Surveillance processes as follows.

Essential Job Duties

• Work with the various cross functional technical and global regulatory affiliates, to intake new and revised regulations/standards, identify gaps and actions plans, and implement needed product/process updates, to remain in compliance to applicable to Laws, Regulations, Standards and Guidance's (LRS&Gs).

• Improve departmental processes and tools needed to manage the landscape of all applicable regulations and standards, across Intuitive's product portfolio, and global footprint.

• Reviews, analyses, and approves Regulatory Surveillance Assessments and integration plans to verify compliance to LRS&Gs.

• Initiate, drive, and participate in cross-functional meetings to advance Regulatory Surveillance Assessment activities.

• Effectively work with product owners, project managers, technical SMEs and regulatory and quality functions to drive and implement the changes effectively.

• Liaises SME and RA to facilitate completion of assessments. Incumbent works closely with the local process owners and business partners ensure RSM procedures are followed, and appropriate evidence/record is established.

• Receives and compiles information from Global Surveillance actions.

• Maintains publications per DOP, Process for External Standards Library. - Initiates External Standards Forms in Agile (ACCS) as needed.

• Initiates Assessment Forms and tracks SME assignments.

• Participate in audits, change review processes, and other review boards as needed.

• Negotiates RSA due dates and extensions.

• Compiles and reports process metrics and KPIs; provides periodic process timeliness reports and reminders to SMEs to help keep assessment and Implementation activities on-target.

• Updates and maintains all aspects of the Standards Database and information necessary for Intuitive's local functions and circulation of such information as required. Partners with process owners to ensure assessment, identification of, and adherence to requirements and process.

• Prepares periodic updates as required by leadership and management forums (i.e., Quality Review Board (QRB), Management Review, etc.)

• Other activities as identified by RSM management.

Qualifications

Required Skills and Experience

• Proven knowledge and knowledge of global medical device regulations and standards

• Experience specifically with FDA QSR, CE marking Regulations, and ISO 13485 is required.

• Familiar with project management tools like Smartsheet and Microsoft Project.

• Excellent communication and relational skills to effectively partner with cross-functional teams.

• Familiar with various regulatory databases & industry publications

• Detail-oriented with steady organizational and project management skills.

• Self-motivated

• Excellent verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.

• Excellent relational skills, ability to work with others in a team environment, effective interactions in cross-department teams.

• Fast learner and able to learn internal procedures and processes and implement the same on project teams.

• Very organized for systemic monitoring of LRS&Gs.

• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Access, Outlook), experience with Agile PLM a plus.

• Facility with Smartsheet, MS-EXCEL charts and data functions (Filter, Sort, COUNTIFS) , MS-WORD (Mail merge capability a plus)

• Facility with Agile or similar Automated Change Control System (Search and monitor workflows of existing change orders. The ability to create change orders (completing the title page, uploading documents, and running the approval matrix) is a plus.

• Ability to exercise autonomous judgment and discretion within a broadly defined range of policies and practices. This includes thorough problem-solving.

• Demonstrated organizational and planning skills, including action-oriented focused urgency, and driving for results.

• Ability to effectively manage complex projects with ambiguity and rapid change.

• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.

• Detail-orientated, with emphasis on accuracy and completeness.

• Ability to travel up to 20%

• This role requires proven and good expertise and knowledge of global medical device regulations and standards, the ability to drive and influence change management.

Required Education and Training

• Minimum Bachelors or higher or equivalent work experience required.

• 5+ years working in a medical device company

• Experience working with cross-function teams including engineering, manufacturing, regulatory, quality, etc.

• Experience using business analysis techniques such as process flows, gap analysis, and risk management processes.

• Experience speaking and working with management to improve processes.

• Exceptional aptitude for cultivating partnerships across department boundaries and influencing cross-functional teams without formal authority to ensure project success.

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.

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 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.