Acumed
  • 04-Jan-2018 to 31-Mar-2018 (PST)
  • Regulatory
  • Hillsboro, OR, USA
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, PTO, Fitness Reimbrusement, Costco Membership, Tri-Met Pass, and more!


We're looking for a motivated Regulatory Specialist to help create, develop and maintain materials needed for regulatory compliance. This key role helps support Company compliance activities, new product submissions, listings, and registration of medical devices.

Duties/Responsibilities

  • Understands regulations, follows complex directions, and investigates when clarification is needed.
  • Initiates International product registration, including renewals or changes and certificates for foreign governments
  • Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark
  • Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.)
  • Participates in the preparation and execution of ISO and FDA audits
  • Assures regulatory compliance and content accuracy of Technical Files and 510(k) files
  • Completes the duties described in the Quality Manual
  • Converts and/or approves ECRs/ECOs requiring regulatory review
  • Assists in package insert (instructions for use) development, organization and application
  • Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products
  • Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations
  • Reports standards changes and summarizes impact on Acumed products
  • Involvement in new country/market registration as required
  • Assists in labeling (e.g. package inserts/IFUs(instructions for use), marketing materials, package labels, etc.) development, organization, application and/or review
  • Assists in development of company regulatory strategies and determine priorities with Sales & Marketing, Engineering and Quality
  • Reports standards changes, determines impact and takes appropriate action

Qualifications

  • Masters of Science in Regulatory Affairs, Biology, Chemistry, Engineering or related field required and 5+ years of regulatory experience in medical device or equivalent industry; or Bachelor's degree and 6+ years of regulatory experience in medical device or equivalent industry
  • Evidence of applied knowledge of applicable FDA, CMDCAS, ISO, MDD, region-specific requirements and consensus standards
  • Ability to work with FDA, Notified Body, EU Authorized Representative and other global regulatory agencies
  • Able to manage multiple projects simultaneously
  • Proven track record of strong team work, creatively strategic thinking
  • Ability to work well with others, support regulatory activities and mentor/train others
  • Excellent written and verbal communication skills
  • Ability to read and speak English sufficiently to read, understand and complete all documentation
  • Regulatory Affairs Certification (RAC) preferred

 

Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

Acumed
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