Hello I'm Komal from Intellectt we have an opening for a Project Manager I in St. Paul, MN - 55117 or Temecula, CA. Please find the job details and description below and if interested You can reach me at or call me at .
Role : Project Manager I
Location : St. Paul, MN - 55117 or Temecula, CA
Duration : 12 Months on W2
Shift Timings: 8 AM to 5 PM 100% Onsite role in St. Paul, MN - 55117 or Temecula, CA (Mention on top of resume where the candidate wants to work from). Open to candidates who are willing to relocate to the site location at their own expense. No possibility for hybrid or remote. 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. 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. 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. Interview Process: Three individual interviews over a video for about 45 minutes to 1 hour. Possibility for a second round for the top candidates. Candidates are expected to be on camera during the interview.
