Medical Device Labeling Specialist

Overview
The Medical Device Labeling Specialist will assist the Medical Device Labeling Manager with creating, implementing, and all device labeling as defined by the FDA which includes all labels and other written, printed or graphic matter 1) upon any article or any of its containers or wrappers or 2) accompanying such article at any time while a device is held for sale, after shipment, or delivery for shipment in interstate commerce 3) marketing deliverables including posters, tags, pamphlets, circulars, booklets, brochures, instruction books, directions sheets, fillers, web sites, third party articles, and user training documentation. This position will act as a liaison between Marketing, Engineering, Sales and Support, and Quality/Regulatory teams to help meet growing demands.

Responsibilities (other duties may be assigned)

· Maintains attention to detail.

· Promote and maintain medical device labeling to the highest standards.

· Responsible for graphic layout of IFUs and other “labeling” documents, as well as executing all updates to current IFUs and other labeling documents (such as clinical IFUs, research manuals, overlays, etc.).

· Update and maintain an inventory of marketing materials for external customers, along with documents and materials to help support the Sales and Support team in their efforts to support customers and make sales.

· Prepare IFU translation files for quote/job, keeping track of the fiscal year’s translation costs to help in preparing next year’s budget.

· Complete and circulate all QSF41 quality documents along with corresponding Labeling to the necessary reviewers, then maintaining a copy in the marketing master files.

· Maintain the most current revision of all appropriate marketing material on the Website, along with responding to all IFU requests for the web with the correct IFU in a timely manner.

· Responsible for product and staff image library.

· Support written communication and content marketing efforts, when needed.

· Back-up support for FHC’s websites.

· Manage FHC’s trademarks, including expiration and renewal

· Assist with New Hire Functions- take badge photos and upload them to SharePoint and the website.

· Abides by all policies and procedures in the QMS system.

Skills

Bachelor's degree in communications, marketing, advertising, or equivalent work experience in one of those fields. Knowledge of various media options including hands-on ability to develop concepts, copy, and presentation alternatives. Good math skills in order to interpret market research data, trends, and customer survey results, a plus.

High level of energy, positive attitude, strong confidence, mature decision making ability, demanding nature for quality and customer service excellence, and a passion for promoting the well-being of the company, its products, its employees, and its customer benefit. Understanding of international markets, including selling, marketing, regulatory, and distribution techniques.

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person

Salary : $60,000 - $70,000