GRA Labeling Manager

Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Biomedical engineering, etc.) or Equivalent years of directly related experience (Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience

Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, Health Canada and ISO.
Oversee the management, review, and approval of Medical Device Labeling Content and artwork for various products, ensuring regulatory and internal compliance.
Support regulatory objectives such as Post-Production Risk Reviews (PPRR), Risk Management Report (RMR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation.
Manage and implement harmonization activities to ensure consistent labeling across different markets and handle variations in response to unique local/regional requirements and regulatory changes.
Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.
Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.
Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes.

Deep understanding of global medical device regulations including: FDA21 CFR part 801, European MDR/IVDR, and other labeling standards
Familiarity with ISO standards related to labeling such as ISO 20417, ISO 15223-1, and ISO 13485
Knowledge of labeling requirements across major markets including, US, EU, and Canada
Ability to think strategically, navigate ambiguity, and decision-making