Project Manager, Regulatory

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Company: TriSalus Life Sciences

Location: Westminster, CO 80031

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.

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