- Manage annual global Regulatory Strategy and Planning process to support multiple franchises and commercial strategies.
- Own overall Regulatory portfolio and coordination of activities to successfully execute to program timelines including downstream implementation activities.
- Interface with the R&D portfolio management process and phase gate review process to ensure Regulatory projects are supported and prioritized.
- Support resource allocation process for Regulatory.
- Function in a leadership role and leads large, complex, technically challenging programs consisting of cross-functional teams.
- Delegate and supervise work activities and support personnel to meet project objectives.
- Own success factors such as progress, schedule, budget, project risks and resource or needs gaps and maintaining effective communication to all stakeholders.
- Lead development and execution of regulatory project plans, and timelines for domestic and international regulatory activities to support regulatory strategy and other major initiatives.
- Identify and manage risks, issues, and dependencies associated with project.
- Collaborate with cross-functional teams, including Marketing, R&D, R&D PMO, Quality, Manufacturing, and International to ensure project success.
- Facilitate communication and collaboration among team members and stakeholders, providing regular project updates and progress reports to leadership.
- Conduct project post-mortems to identify areas for improvement and best practices to be shared across the organization.
- Preferred Minimum Non-Technical Degree: Bachelors Degree
- Preferred Minimum Technical/Advanced Degree: Bachelors Degree in engineering or life sciences
- Preferred Minimum Non-Technical Degree: 10+ Years
- Preferred Minimum Technical/Advanced Degree: 8+ Years with Masters Degree, 5+ Years with PhD
- Experienced with ISO and FDA quality systems regulations and medical device design and development cycles.
- Minimum 2 years prior experience in regulatory in the medical device industry.
- Prior experience with global product launches or international regulatory is beneficial.
- Prior experience in leading new product development is beneficial.
- Excellent leadership, communication, and interpersonal skills.
- Ability to lead and motivate a high performing team; efficiently direct and coordinate the work of others.
- Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals.
- Expert in management of project risks, design control procedures, Microsoft Office, Microsoft Project, PPM tools, such as Smartsheet, Planview, reporting dashboards, etc.
- Experience in a Medical Device phase/gate approach to New Product Introductions (NPI)
- Demonstrated success leading programs that delivered commercially successful products in a regulated industry.
- Ability to simultaneously manage multiple large-scale projects in various lifecycle stages, balance priorities and provide support to multiple workstreams.
- Demonstrated experience in project management, portfolio management and/or analyst roles- medical device and/or engineering.
- Experience in delivering global product introductions, with consideration of regional commercial collateral needs at to the satisfaction of the global regulatory landscape.
- Strong technical aptitude, analytical, business management and strategic thinking skills
- Self-starter with a strong proactive work ethic, well-organized and detail-oriented
- PMP Certification is beneficial.
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Program Manager - Newark, United States - Hologic
Description
Program Manager
Newark, DE, United States
Hologic is seeking a Program Manager to join our expanding Innovation Center located in Newark, DE. This is wonderful opportunity to support our Breast and Skeletal Health division, organizing cross-functional activities, ensuring the completion of programs and projects. Apply today
What to Expect:
The Program Manager will support Regulatory and will drive success of large multi-franchise, complex programs and manage the global Regulatory planning and strategy process for Breast and Skeletal Health. We expect the Program Manager to organizing cross-functional activities, ensuring completion of programs/projects and supporting status updates to leadership.
What We Expect:
Education
Experience
Skills
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We cant wait to hear from you
The annualized base salary range for this role is $87,900 - $137,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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