Acumed
  • 20-Jun-2019 (PST)
  • Regulatory
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Paid Time Off, Floating Holidays, Tuition Reimbursement Program, TriMet Pass, Costco Membership, Summer Hours and more!


About Us

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Regulatory Specialist II

The Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.

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.
  • Provides regulatory training to lower level regulatory personnel.
  • ¬†

Qualifications

  • Bachelor of Science in Biology, Chemistry or related field required.
  • Thorough working knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards.
  • 3 - 5 years of regulatory experience or 5+ years of experience in the medical device or equivalent industry (quality or orthopedic engineering).
  • Ability to support and execute activities related to product development teams and projects.
  • Ability to work well with others and manage projects.
  • Excellent written and verbal communication skills.
  • Ability to read and speak English sufficiently to read, understand and complete all documentation.

Acumed and ACUTE are equal opportunity employers. 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.

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