Regulatory Affairs Associate

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Regulatory Affairs Associate

November 2020

HemoSonics, LLC is seeking a Regulatory Affairs Associate who will be responsible for maintaining the regulatory aspects of labeling, drafting new and revising existing artwork, as well as providing support for other regulatory affairs activities. The labeling projects include coordination of language translations for English labeling materials, GTIN and UDI logs, management of files and completion of internal approvals. The product projects include update of CE Mark Technical Files.

Key Attributes of the Successful Candidate:

  • Good understanding of regulations and requirements for US market through expert knowledge, FDA Guidance Documents, ISO Standards, Code of Federal Regulations as they pertain to medical device or IVD product labeling.
  • Knowledge of and experience applying 21 CFR 801 and 820 regulations
  • Knowledge of Unique Device Identifier requirements
  • Knowledge of International medical device labeling standards is preferred
  • Demonstrates the ability to ensure high quality labeling is generated and maintained.
  • Must have excellent written and verbal communication skills
  • Must be able to prioritize and handle several projects concurrently
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
  • Strong analytical skills (creating and following procedures) and solving procedural roadblocks
  • Must be able to meet goals on time
  • Familiarity with document or content management systems concepts a plus
  • Advanced computer skills (Excel, PowerPoint, Word, etc.)

Key Responsibilities:

  • Responsible for the overall coordination, development and execution of labeling projects (including obtaining translations for all labeling) for HemoSonics product portfolio
  • Review and approve labeling updates to ensure compliance with global requirements and provide regulatory support where needed
  • Complete revisions of existing labeling via the Change Request process
  • Create new labeling associated with new product development
  • Update and maintain the product CE mark Technical Files according to Change Requests and new product launches
  • Correspond with European Authorized Representative on product updates
  • Maintain the UDI/GTIN log for HemoSonics products
  • Stays current with emerging regulatory labeling guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices
  • Actively looks for ways to improve current processes within department and across the business to gain efficiency and quality labeling
  • Review and approve changes, advertising, promotional items and labeling for regulatory compliance
  • Provide general support for platform regulatory team and projects, as needed

    Education and Experience Required:

    • Bachelor’s degree in Science, Regulatory Affairs, Engineering, or related field, plus 2 years of work experience in a regulated environment (medical device preferred); or equivalent combination of education and experience
    • Experience in supporting regulatory labeling for new products and changes to labels for existing products in meeting global regulatory requirements
    • Experience working as a member of a team in a timeline-driven environment with limited supervision is required
    • Experience working in IVD industry a plus
    • Technical Writing and editing experience is preferred.

    The position is based in Durham, NC.

    To apply, please email your cover letter, resume and salary requirements to:

    HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

    Why HemoSonics?

    HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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