Project Manager, Regulatory Affairs (Medical Device)

  •  

Boston, MA

Industry: Manufacturing

  •  

5 - 7 years

Posted 26 days ago

  by    Danielle Schweizer

Lead regulatory a?airs focused projects that produce new and/or improved strategies, processes, procedures and protocols to ensure internal and external compliance.

Job Responsibilities:

  • Drive RA focused projects and act as project lead where required
  • Develop and/or improve development processes, procedures and protocols that assist in meeting internal SOP's, FDA and industry regulations
  • Determine global regulatory strategies for market introduction of new and modi?ed devices/platforms
  • Ensure proper communication of regulatory strategies to responsible functions, including Product Development, Sales, Marketing, Service, Manufacturing and Executive Management (as necessary)
  • Prepare and maintain US and non-US product submissions (510(k), Technical Files, Canadian Licenses and International registrations)
  • Participate in product development teams, as well as, review, analyze and comment on technical protocols and reports
  • Provide guidance and training to teams as necessary on regulatory requirements
  • Provide regulatory reports and inputs to management as necessary
  • Translate the regulatory requirements into the relevant implementation.
  • Review, approve and provide guidance for labeling and advertising
  • Interact with US and non-government officials on product approvals and during audits
  • Ensure proper facility registrations and device listings for DMSI with appropriate regulatory agencies
  • Maintain Regulatory Databases as necessary
  • Performs other duties as needed and assigned

Education:

  • BA/BS degree in business, engineering, medical or scienti?c discipline
  • Minimum 5 years of regulatory experience in a medical device regulatory function(s)

Related Experience:

  • Experience in preparing sand submitting Class II marketing applications to regulatory agencies
  • Extensive knowledge and understanding of US, European and International medical device regulations, standards and guidance documents REQUIRED
  • Knowledge and understanding of QSR and ISO quality management system documentation requirements
  • Special Competencies or Certifications: Project Management skills
  • Degree in RA or Regulatory Affairs Certification a plus
  • Able to apply problem-solving skills for problems of moderate to diverse scope
  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements
  • Strong interpersonal, written and oral communication skills Strong computer skills and knowledge of databases
  • Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
$100K - $120K
$100K - $120K base, Bonus Available: tbd; max salary estimate $115,00 bonus