Project Manager
2 weeks ago
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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