IVDR Senior Project Manager

Job Description

Be a part of the future of Precision Medicine at Agilent!
In the Companion Diagnostics (CDx) Division of the Life Sciences and Diagnostics Market Group (LDG), we partner closely with leading pharmaceutical companies to develop, manufacture, and commercialize regulated IVD medical devices, which are critical to help physicians select therapies for cancer patients.

In this exciting role, you will help Agilent to lead the way in companion diagnostic product development. Reporting to the Program Manager, you will work closely with cross-functional project teams in a matrix organization to support diagnostic device study submissions to meet EU IVDR regulatory requirements. You will be externally facing to pharma partners and collaborate with internal stakeholders in sourcing and regulatory organizations to ensure project objectives are accomplished on time and within budget.

• Responsible for scoping work plan, leading cross-functional project team, and supporting execution of medium and large scale, moderate to complex projects with global regulatory submission requirements

• Maintains project timelines, milestones, and risk mitigations with customer, vendor, and internal teams

• Facilitates agenda-driven internal and external meetings, shares minutes, and documents action items

• Requires ability to work independently in collaboration with internal stakeholders and external partners

Qualifications

• Requires Bachelor's or Master's Degree or equivalent; PMP and/or RAC-Devices certification a plus

• 8+ years leading cross-functional project teams with moderate or complex regulatory requirements

• 5+ years in a regulated industry such as diagnostics, medical devices, pharmaceuticals, or biotech

• Knowledge of product development process and project management tools (Gantt, timelines, etc.)

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 3, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $130,240.00 - $244,200.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: R&D