• 27-Apr-2017 to 26-Jun-2017 (CST)
  • Regulatory
  • Edina, MN, USA
  • Salary
  • Full Time

Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay

Be involved with a company that is changing the lives of people across the globe.

ARKRAY is currently looking to fill a Regulatory Affairs Specialist position responsible for managing regulatory projects and activities to ensure compliance to ISO 13485 standards and FDA regulations.


Duties and Responsibilities

  • This position is the primary owner of all product labeling. This includes the creation, aggregation and organization of labeling content and the ownership and management of the entire labeling creation process, resulting in released labeling artwork files for supplier production of the material by our material sourcing group.
    • Collaborate with cross functional team to initiate, create or revise product labels and labeling. Significant writing, editing and review activities will be required.
    • Coordinate design priorities of the project work and the specific artwork revisions with internal graphics designers.
    • Review product labels and labeling to ensure compliance with applicable FDA regulations, ISO standards, and company procedures.
    • Coordinate the review and approval of labels and labeling with required departments and stakeholders.
    • Manage translations of documents when needed.
    • Work with all departments to ensure proper control and maintenance of artwork files.
    • Maintains product labeling program and implement process and procedural improvements as needed.
  • Participate in project launches. Works with team to ensure product launch activities are completed on time.
  • Ensure ARKRAY is current on FDA guidelines and other regulatory information from the internet, FDA database, and other appropriate sources
  • Manage FDA establishment registrations and device listings for U.S. and global compliance
  • Conduct annual risk review of ARKRAY marketed products
  • Coordinates product recall activities
  • Manage OUS submissions
  • Provide support to currently marketed products as necessary.
  • Maintain the record retention and archiving program for company regulatory documents, both paper and electronic.
  • Perform Quality Systems Departmental projects and tasks as needed and/or assigned.

Knowledge and Skills:

  • Associates or technical degree, BS degree is preferred
  • Three years' experience in the IVD or medical device industry in a regulatory compliance and/or quality assurance role.
  • Knowledge of FDA labeling regulations 21 CFR 801 and 809
  • Experience with creating, reviewing and approving medical device labels and labeling
  • Ability to learn new skills and adapt to business needs
  • Experience working in a team environment and ability to collaborate with all levels of the organization
  • Good written and verbal communication skills
  • High attention to detail
  • Ability to coordinate multiple projects and prioritize workload
  • Excellent Computer Skills; inclination to adopt technology to maximize efficiency

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.

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