Regulatory Affairs Specialist (Labeling/Promotions/Registrations) – Medical Device/Direct Hire
Our client, an RTP area medical device company in high growth mode, is actively recruiting for a sharp, knowledgeable and self-directed candidate to assume a key role on its Regulatory and Quality team.
This is one of the fastest-growing companies in the Triangle. It is developing point-of-care diagnostic tools and initial products are on-the-market in Europe and the US. The company is building for its future, and this is an outstanding foot-in-the-door opportunity.
The Regulatory Affairs Specialist 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.
Specific responsibilities will include:
- Coordinating, developing, and executing labeling projects including language translations for English labeling materials, GTIN and UDI logs, management of files
- Updating and maintaining the product CE mark Technical Files according to Change Requests and new product launches
- Reviewing and approving labeling updates to ensure compliance with global requirements
- Completing revisions of existing labeling via the Change Request process
- Corresponding with European Authorized Representative on product updates
- Reviewing and approving changes, advertising, promotional items, and labeling for regulatory compliance
- Maintaining the UDI/GTIN log for all products
- Suggesting ways to improve current processes to gain efficiency and quality labeling
- Providing general support for platform regulatory team and projects, as needed
Targeted candidate will offer a scientific BS degree as well as 2+ years of directly-related Regulatory Affairs experience, with particular expertise in labeling. Other priorities include:
- Device/diagnostic experience; familiarity with IVD is a plus
- Experience working with new product introduction as well as changes to existing products
- Knowledge of U.S. medical device regulations and standards
- Knowledge of 21 CFR 801 and 820 regulations
- Knowledge of international medical device labeling standards (ISO 15223-1)
- Knowledge of Unique Device Identifier requirements
- Excellent written and verbal communication skills; technical writing/editing important
- Advanced computer skills (Excel, PowerPoint, Word, etc.)
- Keen attention to detail and accuracy
Finally and critically, we seek a can-do candidate who will work exceedingly well in this hands-on, dynamic, empowered setting. A lot is happening. We seek a skilled and driven overachiever who will thrive.
This is a Direct Hire opportunity and compensation will be generous.
Please forward Word resume for prompt consideration. Local candidates only.