Regulatory Affairs Specialist

Company: Rangam Consultants Inc.
Location: Santa Clara
Posted on: January 25, 2023

Job Description:

I am ok with 2 years but it has to be in medical devices RA (not quality, not IVD, not drugs)

Otherwise 3-5 years experience may be more likely appropriate

Summary:

• Looking for someone with 2+ years exp specifically international intermissions or writing they will be working on over 100 country submissions.
• Prefer regulatory background with medical device
• Quality systems
• Tech files work
• Complex product
• They work on drug eluding stents documentation
• Regulatory and technical knowledge
• Be able to follow proceduresDuties:
  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Identify opportunity for regulatory affair processes and drive changes to completion.Other skills:
    • Good communication skills working with international sites
    • Break down questions and discussion in detail
    • Prioritize what the ask is and workload they have
    • Learn quickly and understand details
    • Thinking strategically plan ahead
    • Asking questions.Preferred:
      • Change management experience, international registrations and submissions.
      • Must have excellent communication skills and follow up.
      • Must know how to use Microsoft Outlook, Excel, Word and Powerpoint.
      • From a perspective of soft skills
      • looking for someone who can work independently with direction and is able to project plan.
      • They need to be doers and enthusiastic about the job. background in Class 3 medical devices is a plus good communicator and should be proficient at able to use microsoft office, excel and wordYears Experience:
        • Must have 3-5 years of experiences in Medical Device Regulatory AffairsSkills:
          • Have working knowledge in EU MDR
          • Have working knowledge in Regulatory Change Assessment in
          • Have working knowledge in US and EU medical device submissions
          • Have experience supporting internal and external inspections
          • Work cross-functionally and in a matrixed environment
          • Have experience with continuous improvement activitiesEducation:
            • BA Degree Required
              
              About Rangam:
              Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
              Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.

Keywords: Rangam Consultants Inc., Santa Clara , Regulatory Affairs Specialist, Other , Santa Clara, California