Project Manager, Regulatory

1 month ago

Westminster, United States Trisalus Life Sciences, Inc. Full time
Job DescriptionJob Description

Duties and Responsibilities:

  • Serve as Regulatory Operations project team lead and collaborate cross-functionally to assure prioritization and completion of high-quality (clearly written, cleanly formatted/proofed) regulatory submissions, compliant with global regulatory requirements and company operating procedures.
  • Lead interdepartmental teams to complete an assigned project on time, to specifications, and with accuracy and efficiency.
  • Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution.
  • Conduct risk assessments: report identified risks to management (with briefing materials, as indicated), provide recommendations for mitigation of risk.
  • Develop and maintain integrated regulatory project plans. Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, and mitigation management (and proposed solutions to support decision-making) for assigned programs. Collaborate with Regulatory Affairs’ members in presenting operational strategies/status of plans to key stakeholders
  • Outline tasks involved in a project and delegate as appropriate.
  • Conducts cost analysis, estimating expected costs for the project.
  • Facilitate drafting/review/execution of contracts for department. File appropriately. Track timing for any necessary renewals/amendments.
  • Prepare and implements budget, working with line management.
  • Addresses questions, concerns, and/or complaints throughout the project.
  • Develop closed document management system for Regulatory Affairs/Clinical Operations, including oversight responsibility for vendor contracts.
  • Supervise any retained/assigned FTEs responsible for active maintenance of document system
  • Develop and maintain department standard operating procedures in collaboration with line management.  Reports to Chief Regulatory Affairs Officer

Required Knowledge, Skills & Abilities:

  • Understanding of regulatory standards/requirements relevant to global drug and device development and post-market requirements with pro-active approach to increasing knowledge through self-education/identified formal training.
  • Demonstrated leadership, problem-solving ability, flexibility, and teamwork
  • Meticulous attention to details; resourcefulness
  • Proven ability to provide regulatory operational support and guidance.
  • Able to deal with issues of critical importance, provide regulatory operational advice, and make reasoned decisions on regulatory operational issues.
  • Maturity of judgment; ability to elevate and communicate actual and potential issues
  • Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
  • Excellent interpersonal and negotiation skills; ability to integrate into development teams.
  • Excellent computer proficiency (MS Office – Word, Excel, Access and Outlook)
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
  • Commitment to continuing Professional Development in PM, including completion of PDUs annually and progress toward a PMP certification.

Education & Certifications:

  • Project Management Certification (Min. Certified Assoc PM) required – or the ability to obtain the PMP within the first two years
  • Associate’s degree required Bachelor’s preferred

Work Experience:

  • Minimum 8 years’ experience with increasing responsibility in project coordination and management

Physical Requirements:

  • Prolonged periods of sitting at a desk, working at a computer
  • Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
  • Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.

  • Regulatory Operations Project Lead

    3 weeks ago

    Westminster, Colorado, United States Trisalus Life Sciences, Inc. Full time

    Job OverviewWe are seeking a highly skilled Regulatory Operations Project Lead to join our team at Trisalus Life Sciences, Inc.

  • Regulatory Department Manager

    3 weeks ago

    Westminster, Maryland, United States LifeBridge Health Full time

    About LifeBridge HealthWe are one of the largest healthcare providers in Maryland, serving over 1 million patients annually.Our team is dedicated to delivering exceptional patient care and making a positive impact in our community.Job SummaryWe are seeking an experienced Regulatory Department Manager to join our team at Carroll Hospital. As a key member of...

  • Project Manager

    3 weeks ago

    Westminster, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are looking to onboard a Project Manager in Westminster, Maryland. Operating within the energy industry, the role entails overseeing diverse projects, handling administrative functions, and facilitating interdepartmental coordination. This role offers a short term contract employment opportunity.Responsibilities:• Oversee...

  • Regulatory Compliance and Accreditation Specialist

    3 weeks ago

    Westminster, Colorado, United States LifeBridge Health Full time

    Job DescriptionWe are seeking a seasoned professional to fill the role of Regulatory Compliance and Accreditation Specialist at LifeBridge Health. As a key member of our team, you will be responsible for ensuring that our hospital maintains compliance with regulatory standards and accreditation requirements.About the RoleThe successful candidate will have a...

  • Project Engineer

    1 month ago

    Westminster, United States W3Global Inc. Full time

    Job DescriptionJob DescriptionThe Project Engineer is responsible for leading technical aspects of defense projects, from conception to completion, ensuring alignment with technical, contractual, and regulatory requirements. The role requires close collaboration with cross-functional teams, including design, manufacturing, quality, and supply chain, to drive...

  • Senior Defense Project Lead

    3 weeks ago

    Westminster, Colorado, United States TriMech Services Full time

    Job OverviewWe are seeking a seasoned Senior Defense Project Lead to join our team at TriMech Services. This role involves overseeing the technical aspects of defense projects, ensuring alignment with technical, contractual, and regulatory requirements.The ideal candidate has a strong technical background in engineering within the defense industry and is...

  • Schedule Project Manager

    3 weeks ago

    Westminster, Colorado, United States Sargent & Lundy Full time

    At Sargent & Lundy, we are seeking a skilled Schedule Project Manager to join our team. This is a full-time position in our Project Controls and Scheduling Division, reporting directly to the Chief Operations Officer Group.About the RoleWe are looking for an experienced project manager with expertise in schedule management and control. As a Senior Scheduler...

  • Project Management Intern

    4 weeks ago

    Westminster, United States Trimble, Inc. Full time

    Assist in project planning, scheduling, and monitoring to note milestone achievements, task completion, and change management activities- Ensuring effective and timely communication with project stakeholders with the appropriate level of frequency an Project Management, Management, Intern, Business Services, Manufacturing, Business, Skills

  • Project Management Intern

    2 weeks ago

    Westminster, United States Trimble, Inc. Full time

    Assist in project planning, scheduling, and monitoring to note milestone achievements, task completion, and change management activities- Ensuring effective and timely communication with project stakeholders with the appropriate level of frequency an Project Management, Management, Intern, Business Services, Manufacturing, Business, Skills Learn More

  • Construction Project Manager

    20 hours ago

    Westminster, Colorado, United States PRADELL BUILDERS INC Full time

    We are seeking a highly skilled Construction Project Manager to oversee the successful delivery of commercial construction projects. The ideal candidate will have previous experience in construction management or a related field and possess strong leadership qualities.Job Responsibilities:Oversee all aspects of construction project on site, ensuring high...

  • Project Management Intern

    4 weeks ago

    Westminster, United States Trimble Inc Full time

    Title: Project Management Intern Job Location: Westminster, CO; Sunnyvale, CA; Dayton, OH; Portland, OR Our Department: All Timing: Summer 2025 About Trimble's Internship Program As a Trimble intern, you will not only gain valuable hands-on experience but will also be given challenging, meaningful tasks that will give you insight into what it's like...

  • Project Management Intern

    4 weeks ago

    Westminster, United States AGCO Corporation Full time

    Project Management Intern Date: Nov 23, 2024 Location: Westminster, CO, US Workplace Type: Onsite Do you want to help solve the world's most pressing challenges? Feeding the world's growing population and slowing climate change are two of the world's greatest challenges. AGCO is a part of the solution! As an intern, you will be an important part of the...

  • Site Project Manager

    2 weeks ago

    Westminster, United States Disability Solutions Full time

    Air Squared Manufacturing IncDescription: Company: Air SquaredTitle of Position: Engineering Project Manager Position Type: Full time; ExemptAir Squared Manufacturing, LLC is an OEM manufacturer of scroll type compressors, vacuum pumps and expanders for the medical, aerospace, fuel cell and power generation industries. Air Squared offers exciting career...

  • Project Management Intern

    4 weeks ago

    Westminster, United States AGCO Corp. Full time

    Do you want to help solve the world's most pressing challenges? Feeding the world's growing population and slowing climate change are two of the world's greatest challenges. AGCO is a part of the solution! As an intern, you will be an important part of the team right from the start and can look forward to exciting work. We are interested in your ideas as it...

  • Project Management Intern

    4 weeks ago

    Westminster, United States AGCO Corporation Full time

    Date: Oct 25, 2024 Location: Westminster, CO, US #job-location.job-location-inline { display: inline; } Workplace Type: Onsite Do you want to help solve the world's most pressing challenges? Feeding the world's growing population and slowing climate Project Management, Management, Intern, Business Services, Manufacturing, Project

  • Project Management Intern

    2 weeks ago

    Westminster, United States AGCO Corporation Full time

    Date: Oct 25, 2024 Location: Westminster, CO, US #job-location.job-location-inline { display: inline; } Workplace Type: Onsite Do you want to help solve the world's most pressing challenges? Feeding the world's growing population and slowing climate Project Management, Management, Intern, Business Services, Manufacturing, Project Learn More

  • Geomatics Project Manager

    20 hours ago

    Westminster, Colorado, United States Ascent Geomatics Solutions Full time

    Job OverviewAscent Geomatics Solutions is seeking an experienced Crew Chief to join our team. This position offers a competitive salary of $65,000 - $80,000 per year, depending on experience.ResponsibilitiesManage field data collections and equipmentOversee junior staff members and provide trainingCollaborate with project managers and clients to ensure...

  • Project Management Internship Role

    3 weeks ago

    Westminster, Colorado, United States Trimble Inc Full time

    At Trimble Inc, we're looking for a skilled Project Management Intern to join our team. This internship offers hands-on experience in project success and working alongside engineering, product management, and development teams.Job SummaryThis role is perfect for students majoring in business management, analytics, or a related field. As a Project Management...

  • Construction Project Manager Assistant

    3 weeks ago

    Westminster, Colorado, United States U.S. Engineering Full time

    About U.S. EngineeringU.S. Engineering has been an industry leader since 1893, and our success is built on constant innovation and a willingness to evolve.Our VisionWe cultivate a dynamic workplace where every team member can influence change and make an impact. We know that our most valuable asset is our people, and we strive to provide them with the...

  • Geomatics Project Manager

    20 hours ago

    Westminster, Colorado, United States Ascent Geomatics Solutions Full time

    About the JobWe are seeking an experienced and skilled Crew Chief to join our team at Ascent Geomatics Solutions. This role will be responsible for managing field data collections, equipment, and potentially junior staff members. The Crew Chief will focus on energy infrastructure projects, including but not limited to Right-of-Way Surveys, easement staking,...