The Opportunity That Awaits You Help make our first impression the best that it can be. This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for product labeling activities. No product can be complete without comprehensive, clear, and compliant labels. As part of the team that ensures our labels meet the user's needs, the Senior Regulatory Affairs Specialist (Labeling) will work closely with other departments across the organization, making this a position that offers a unique breadth of exposure to different medtech compliance and design functions. The ideal candidate is a motivated regulatory professional ready to contribute to the growth of the department while continuing to advance their own understanding of regulatory compliance, technical content creation, and product development. Succeed in this role with your attention to detail, critical thinking, initiative, and creative flair.
What Your Day-To-Day Will Involve- Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
- Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.
- Provide SME input on global regulatory labeling requirements and standards. Apply style guidelines and branding standards to new and modified product labeling. Verify that labeling complies with all applicable requirements
- Manage external service providers in designing graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender
- Create and revise label items within the company's document control system, by drafting and releasing engineering change orders
- Contribute to Labeling department process improvement initiatives
- Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.
The Qualifications We Need You to Possess- Bachelor's degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 years' experience working in regulatory affairs in a medical device company
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
- Experience with Quality Management System Standard ISO 13485 is required
- Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments
- Excellent written communication skills, especially with technical information
- Proficiency in Microsoft Office Suite preferred
- Precise, thorough and analytical
- Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
The Qualifications We Would Like You to Possess - Advanced degree or credential in regulatory affairs preferred
- Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements
- Experience with e-labeling applications and/or content management system applications preferred
- Fluent in graphic design software and/or desktop publishing software
Pay Range for this role:
$121,890 to $143,400
