Demo

Sr EU MDR Regulatory Project Manager

Actalent
Lake, IL Other
POSTED ON 4/5/2025
AVAILABLE BEFORE 6/5/2025

Job Title: Senior Project Manager


Job Description

This role requires expert level communication, organization, and critical thinking skills. A self-starter with the ability to track and manage multiple tasks and competing priorities is required. The applicant must be well-organized with solid experience providing executive level presentations and status reporting.

Responsibilities

  • Lead cross-functional scientific and technical teams in all aspects of project initiation, planning, execution, monitoring, and closure for assigned programs.
  • Lead teams in timely resolution of complex problems, including development of technical solutions, project plans, resourcing plans, and budgets.
  • Accountable for core team performance, creation and management of project schedules, execution of the project, and budget commitments and spend.
  • Interact through program updates and reviews with all functions and levels of management, ensuring effective ongoing communications across teams and stakeholders.
  • Ensure identification and communication of project risks, development of risk plans, and proactive management of risk response strategies.
  • Manage all financial aspects of assigned projects from initiation through close, which may include capital expenditures, functional expenses, and program positioning.
  • Anticipate potential conflict situations for proactive solutions and manage conflict situations to result in win-win outcomes.
  • Work within the guidelines of project management standard performance metrics and regulatory guidelines to apply best practice Project Management skills, methodologies, and standards such as PMBOK.
  • Maximize business results through continuous improvement in the organization's ability to execute programs from identification through implementation.
  • Lead core teams to identify and implement continuous improvement.

Essential Skills

  • Expertise in all aspects of project and program management.
  • Self-motivated/driven with good interpersonal skills and experience in analyzing complex problems and driving high-performing teams.
  • Ability to lead cross-functional teams.
  • Excellent oral/written communication and presentation skills.
  • Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and product development process requirements.
  • Strong leadership and financial acumen skills.
  • Proficiency with scheduling software such as MS Project.
  • Ability to create and maintain project deliverables such as project timelines, meeting minutes, status reports, etc.
  • PMP (Project Management Professional) certification desired.

Additional Skills & Qualifications

  • Minimum of a Bachelor's degree required, preferably in Engineering, Science, or an equivalent discipline. MS/MBA preferred.
  • 5 years of demonstrated success leading multi-site global or enterprise-wide programs in the medical products industry, including 3-4 years of project management experience.
  • EU MDR experience is a plus.

Work Environment

Hybrid in Round Lake, IL. The work environment may require flexibility and adaptability to frequent shifts in direction. The role involves frequent interaction with people and working on group projects. Attention to detail and a drive for achievement are essential. The position allows for autonomy and independence, with opportunities for innovation and leading the team to develop creative solutions even in high-stress situations.

Pay and Benefits

The pay range for this position is $70.00 - $85.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Gages Lake,IL.

Application Deadline

This position is anticipated to close on Apr 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $70 - $85

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