Project Manager

2 weeks ago


Saint Paul, United States Intellectt Inc Full time

Role: Project Manager (Medical Device)

Location: St. Paul, MN - 55117 or Temecula, CA

Duration: 12 Months on W2

Shift Timings: 8 AM to 5 PM


Skills Looking For:

- Implementation of the Eudamed platform to ensure compliance with EU MDR.

- Coordination with multiple functional groups within the organization.

- Compliance with EU MDR requirements, particularly focusing on UTI and device registration, vigilance, post-market surveillance, and clinical investigations.

- Medical device industry experience is strongly preferred and will be given preference.

- May consider pharma background program manager experience who has handled projects on a large scale but first preference will be med device background.

- Familiarity with IT systems and their integration into the project would be beneficial.

- Experience with EU MDR and IT systems integration is a plus.

- Strong leadership, communication, and organizational skills

- Experience in medical devices and familiarity with EU Medical Devices Regulation (MDR)

- Program management experience, preferably with exposure to regulatory affairs.

- PMP certification is a plus.

- Candidates with a regulatory affairs background and extensive experience in program management are also fine provided they have driven large-scale projects till the end.


- Day-to-day Responsibilities: Coordinate with functional teams to identify compliance requirements; Educate team members on regulatory requirements and drive compliance schedule; Communicate and coordinate with IT professionals for system integration; Monitor and drive closure of activities through implementation.


Education and Level of Experience:

- Bachelor's degree in a relevant field.

- PMP certification is a plus.

- 3 to 6 years of experience in program management in the medical device industry.

- Open to looking at candidates with 10 years of experience if they are fine to work at a given bill rate.


Top 3 Skills:

- Strong leadership and communication skills.

- Ability to comprehend and translate complex regulatory requirements into actionable plans.

- Exceptional organizational skills and ability to drive deliverables to completion.


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