An innovative medical tech company based in Marlborough, Massachusetts is currently looking for a Regulatory Labeling Specialist. The company's mission is to provide healthier lives for everyone, everywhere, and every day!
Responsibilities:
- Change management documentation for medical device products
- Handle all administrative tasks such as editing documents, submitting markups, and auditing
- Collaborate with different teams to remain organized and submit charged files to software systems through different processes
- Ensure that all production and design methods are carried out in accordance with ISO Quality System guidelines
- Research, create, and edit medical device product labels and IFUs
- Be flexible with working independently and cross-functionally with different teams
- Conduct updates for labels, cartons, and IFUs to meet standardized criteria
- Conduct updates for MDR changes, notified body, EU authorization rep, etc.
- Actively look for ways to improve current processes and procedures to maximize efficiency and effectiveness
- Solicits training from in-house specialists to help with the development and design of IFUs and product labels
- Reports
Qualifications:
- Bachelor's degree or equivalent relevant work experience
- 5 years of relevant experience in Medical Device labeling is preferred, not required.
- Knowledgeable in Agile software and document change orders
- Well-rounded in MRP, label control systems and regulations, and engineering release rules
- Good understanding of UDI and GUDID requirements
- Proficient in apps such as Microsoft Office, Adobe Acrobat, Photoshop, InDesign, and Illustrator
- Excellent interpersonal skills, organizational skills, and time management
This is a minimum 6 month contract role onsite with possible extensions (temp to hire).
If you are interested, do not hesitate. Apply now!
