Company Profile
Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.
Today, eighty percent of the world’s population lacks access to MRI. Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.
Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility. If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.
Job Title: Global Labeling Specialist
Location: Guilford, CT
SUMMARY:
As the Global Labeling Specialist, you will be responsible for all product labeling for new and sustaining projects. This is a cross-functional role in Systems Engineering and partnering closely with Product Managers, /Marketing, Regulatory Affairs, Quality, Purchasing and Manufacturing. You will be responsible for drafting, revising, approving, and implementing all product labeling for new and sustaining projects. You will ensure compliance with domestic and international regulations, work with suppliers for translation services, packaging suppliers for printed labeling components, and fully own the lifecycle of all Hyperfine labels including the Instructions for Use.
RESPONSIBILITIES:
- Serves as the primary point of contact for all product labeling throughout development, review, and change control processes.
- Serves as the tool expert/owner for advanced authoring/publishing software.
- Maintains labeling requirements and updates based on changes in regulations. Supports development and adherence to labeling processes and procedures.
- Creates new labeling materials to meet requirements and ensures all content for product labeling, Instructions for Use, and equipment manuals meet requirements (legal, regulatory, company, etc.).
- Coordinates cross-functional reviews of product labeling materials and maintains the product labeling files.
- Updates labeling in response to product changes. Identifies impact of changes to all product labeling. Independently drafts edits based on change descriptions and/or ensures proposed labeling content meets requirements and brand standards prior to incorporating.
- Manages the process for translation as assigned. Serves as a project coordinator and vendor liaison for translating document revisions.
- Manages the design transfer process for labeling. Coordinates with manufacturing to release new or updated labels to production.
KNOWLEDGE AND SKILL:
- Knowledge of US and international medical device regulations and standards, especially those related to labeling
- Experience utilizing publishing tools (preferably MadCap) as well as computer-aided design / graphic tools
- Familiarity with product lifecycle management tools and change control processes
- Adept at working on many projects at a time and identifying changing priorities while ensuring adherence to deadlines and project needs
- Demonstrates good judgment in selecting solutions. Builds relationships with technology communications and project management team members.
- Strong organization and communication skills; able to project manage and effectively lead task completion across cross functional teams.
- Technical writing, copy editing, and verbal communication skills.
EDUCATION/EXPERIENCE REQUIRED:
- 3+ years of experience in medical device or similarly regulated industry including experience managing labeling
PHYSICAL DEMANDS:
- Ability to execute under pressure with short turnaround times
- Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of any employment Visa at this time.