Regulatory Affairs Manager (Individual Contributor-Team Lead) - Draeger Medical Systems, Inc. - Job-ID V000002559


  • Andover, MA
  • Permanent
  • Full-time
  • 3 months ago
What will you do At Draeger, our work is dedicated to protecting, supporting and saving lives. We are looking for a talented individual to join our patient monitoring team to help deliver new features and product enhancements that will improve patient outcomes and reduce the cost of medical care around the world. Determine global regulatory strategies for market introduction of new and modified device (technology) platforms. Ensure proper communication of regulatory strategies to responsible functions, including Product Development, Sales and Marketing, Service, Manufacturing and Executive Management (as necessary). Prepare US and non-US product submissions (510(k), Technical Files, Canadian Licenses and International registrations). Participate and support new product development teams, as well as review, analyze and comment on technical protocols and reports. Interact with FDA and non US Government Officials on product approvals, compliance issues and during auditsinspections. Provide input and comment to regulations and standards which may affect company's products and services. Provide training on regulatory requirements and issues to company personnel to assure compliance. Ensure proper facility registrations and device listings are maintained with the appropriate regulatory agencies. Developprovide regulatory reports and inputs into management review as required. Maintain knowledge and application skills of regulations and standards applicable to Draeger. Performs other duties as needed and assigned. Who you are Education BABS degree in business, engineering, medical or scientific discipline. Related Experience Minimum 5 - 8 years of regulatory experience in the medical device industry commensurate with accountabilities described above. Experience in preparing and submitting Class II Marketing Applications tin the US and Class III in Canada. Minimum of 5years experience working with regulatory agencies (e.g. FDA, HC) and Competent Authorities and Notified Bodies. Special Competencies or Certifications Extensive knowledge and understanding of US, European and International Medical Device Regulations, Standards and Guidance Documents Knowledge and good understanding of QSR and ISO Quality Management System Documentation Regulatory Affairs Certification (RAC) a plus Proven record of managing peopleworking on project teams while working on multiple projects Ability to work with minimal supervision, recognize departmental and organizational needs and initiate actionsrecommendations for resolution Excellent Computer skills and writtenoral communication Ability to meet deadlines and work under pressure Knowledge of current ISO 13485, CMDR SOR98-282, MDD 9342EEC, JGMP's and 21 CFR Part 820