Primary Function of Position
The Senior Project Manager, Regulatory Business Systems will work closely with Regulatory, Product Quality, Compliance, and IT organizations. This Senior Project Manager role will manage quality and regulatory business system projects ensuring the product vision, priorities, and solutions are actively serving the functional and cross functional business needs. Primary responsibilities include project management for process and systems maintenance and improvements as well as sustaining support for Quality and Regulatory Business System needs. This role will take responsibility for the delivery of the project deadlines and commitments.
This is a business role and not a solution (IT) role.
Essential Job Duties
- Lead and organize project teams to drive focused results and projects related to
- Regulatory and Compliance related business processes and systems
- Process and business requirement mapping to business systems
- Operating business model analysis and action plan identifications
- Alignment with quality management systems (QMS) requirements
- Standardization of documentation and templates
- Cross functional process improvements
- Change management for processes and systems
- Support growth model strategy to support future state.
- Expand value streams for IT landscape across organization.
- Align with IT Project Managers on systems strategy, schedule, scope, and deliverables.
- Act as a liaison between internal and external management teams to ensure adherence to project plans.
- Provide Business stakeholders with periodic status updates and resolve inefficiencies to help streamline processes.
- Provide input, guidance, training and mentoring related to Regulatory, Quality, Compliance, and related cross functional teams specific to the regulatory business system strategy and mission.
- Maintain business stakeholder relationships.
- Accomplish project objectives by planning and evaluating project related activities and communicating status and project to management on a regular basis.
- Recommend and suggest solutions to meet project's requirements.
- Complete projects on schedule and within budget
- Work with and manage internal cross-functional teams and vendors.
- Identify inefficiencies and streamline processes to optimize productivity and effectiveness.
- Contribute information and recommendations to strategic plans.
- Prepare and complete action plans to implement productivity, quality, problem resolving, identifying trends, determine system improvements, and implement change.
- Enhance department and organization reputation by accomplishing requests, exploring opportunities, and adding value to job accomplishments.
- Establish, prepare, analyze and metrics.
- Develop relevant procedures in support of continuous improvement in the Quality Management System
- Participate as the Business Architecture representative on other projects as requested or needed.
- Willingness to wear multiple hats and take on responsibilities outside of traditional project management duties as needed.
Required Skills and Experience
- Minimum 12+ years relevant experience working in project / program management required.
Previous experience in medical device, life sciences, or pharmaceuticals strongly preferred.
- Experience working with business systems especially electronic quality management systems or regulatory information management strongly preferred.
- Experience in working on both waterfall and agile software projects methodology strongly preferred.
- PMP certification strongly preferred.
- Experience on project management in SaaS based Regulatory Information Management System strongly preferred.
- Excellent stakeholder management required.
- Excellent conflict resolution skills and ability to motivate a project team required.
- Experience with Smartsheet, MS Project, or similar project management software required.
- Strong verbal and written communication skills, proven ability to translate analytical information into effective presentations required.
- Solid attention to detail, organization skills, and extensive ability to multi-task across multiple projects/activities in a team setting required.
Skills and Experience
- Bachelor’s degree with equivalent work experience.
- Non-technical degree with equivalent complex medical device experience acceptable
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.
