MDR Regulatory Affairs Specialist in Raynham, MA at Integrated Resources, Inc

Date Posted: 5/8/2021

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Raynham, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/8/2021

Job Description



•**This role is remote***


Primary Responsibilities
Execute projects in accordance with the cadence.
Support communication strategy to NPD staff to maximize understanding of expected impact from the MDR program to NPI.
Collaborate with stakeholders to develop and maintain project plans.
Create, monitor and analyze project risks and identify mitigation strategies.
Be responsible for all project communications to all cross-functional project stakeholders and communications include project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.
Report metrics of completion status to manager / Leadership Team.
Work with project team to identify and address critical path or roadblock issues.
Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.
Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.
To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable part.
Review and approval of documentation to support Technical Document to meet MDR requirements.
Participate in cross functional teams to discuss and revise documents to meet MDR requirements.
Support submission review process with Notified Body.

Qualifications
A minimum BA/BS Degree with at least 5 years of regulated medical device industry experience (or related) OR a masters degree or higher with at least 6 years of regulated medical device industry experience (or related) is required
Knowledge of Clientpedic implants a plus
Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus
Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
Familiarity with electronic submission preparation a plus
Excellent written and oral communication skills
Ability to handle multiple tasks and be detail oriented