Project Manager Consultant

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

This Project Manager will lead a facility relocation project, supporting Peripheral Interventions (PI), Interventional Cardiology Therapies (ICTx) and Urology (Uro) divisions, and more specifically, play an integral role to meet strategic objectives and milestones for transitioning to a new facility.

Primary responsibilities include ensuring the Quality Management System is effectively implemented for the site by leading the project team and supporting workstreams across functions, business units and sites. This includes successfully transitioning resources, labs and quality systems to the new facility while working with both internal and external stakeholders on project activities through completion.

Additional areas of support include coordination with construction and facility leads for transition planning, stakeholder management, communication and change management.

Responsibilities:

• Lead cross-functional teams across business units and sites Manage multiple workstreams to support the transition, including schedule, scope, costs and resources.
• Develop and implement overall project plans, including cost, schedule, risk, performance and monitor progress against business key objectives and goals.
• People Management: Manages cross-functional teams; leads teams and helps diverse and dispersed project team members to execute towards overall project goal(s); provides input to functional managers on team and team member performance; develops and maintains strong relationships with key functional stakeholders.
• Project/Program Management: Manages key initiating, planning, executing, controlling, and closing processes; develops and implements project plan; builds team ownership and commitment to project plan; mentors and/or coaches other workstream leads; manages project risks.
• Quality / Process / Regulatory Management: Leads team to complete activities to ensure appropriate quality systems are setup and implemented for use to meet current policies, procedures, standards and regulatory requirements for effective management of the overall quality system; identifies and implements quality, process and regulatory needs for facility transition.
• Communications and Reviews: Responsible for team and cross-functional communications; liaison between the team and governing bodies within the overall program as well as business leadership meetings; responsible for project meeting minutes, issues log, metrics, and other key communications. Communicates and influences resolution of cross-functional issues.
• Communication – Communicates effectively with all levels of the organization. Listens actively and encourages the open exchange of ideas and opinions.
• Influence – Influences and motivates others over whom they have no direct control or authority. Wins support through strategic relationships and persuasive communications.
• Collaboration – Models and promotes collaboration and works effectively with others across the project team, organization and stakeholders to achieve goals.
• Team Leadership – Builds trust and generates enthusiastic support from team members, fellow peers, senior management and delivers high impact leadership results.
• Planning – Creates a comprehensive and realistic project plan with prioritized initiatives that align with project goals and builds on previous lessons learned.
• Execution – Drives results by acting with speed and agility and by assigning clear authority and accountability, integrating and aligning efforts across units and functions, and monitoring progress against objectives.

Requirements:

• Bachelor’s degree required, preferably in Engineering or Project Management.
• 4+ years of relevant experience.
• Cross-functional project team leadership experience.
• Must be willing and able to travel between Maple Grove (2) and Minnetonka facilities.
• Hybrid work mode, minimum 3 days a week in the office, with transition to on-site during peak of facility transition.
• Works under minimal supervision.

 

Preferred Qualifications

• Prior medical device and/or regulated industry experience.
• Quality Systems and Regulatory experience.
• The capability to easily navigate, manage and articulate core functional processes.
• Leads courageously by confronting problems directly; moves forward optimistically under conditions of uncertainty.
• Stays current on important trends that impact the business; places customers at the center of project execution.
• Manages the triple constraint; understands the significance, impact and aggressively manages project risks

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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