Regulatory Affairs Specialist

Regulatory Affairs Specialist Duration: 12 months, potential extension Location: Remote (preferred locations: Rochester, NY; Clearwater, FL; St. Louis, MO; or Bridgewater, NJ) Shift Requirements: Monday to Friday, EST hours. This role is responsible for leading labeling artwork development/revisions projects for medical device products, and assessing changes in standards, regulations, and requirements to identify impact to product labels. As a key team member, contributes to the development of labeling processes and procedures to enhance existing practices. Responsibilities Manage and coordinate labeling change requests and content updates for US-only artwork, MDD, MDR, new product launches, private label or regional/country specific projects. Work with regional/country requesters to initiate projects/changes. Liaise with cross-functional SME teams to verify and confirm labeling content. Perform label assessments using labeling processes, forms and checklists. Resolve conflicts of reviewer feedback on labeling content. Work closely with the LRS Coordinator to align and interpret LRS into red‑line versions of artwork. Provide continuous feedback to the LRS Coordinator on any content changes that would impact LRS updates. Participate in LRS meetings with the LRS Coordinator. Act as LRS Coordinator backup. Redline and communicate changes with project teams and disseminate information to the Graphics team for artwork creation. Perform all assigned ELM project tasks. Provide submission artwork support. Provide RA artwork support for health authority submissions (including before/after artworks, redlined PDFs, etc.). Monitor timelines and advise project teams of any impacts to timelines during TG1. Support/review SOPs. Participate in company audits, as needed. Other job responsibilities as needed. Technical Competencies Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle including development, commercialization, and operations. Knowledge of standards and regulations relating to submissions and regulatory approval of device products. Knowledge of medical device industry product labeling processes for review and obtaining regulatory approvals. Strong technology skills and abilities, especially with Microsoft Office programs and web‑based programs. Ability to critically and efficiently review detailed information to support a labeling revision. Professional Competencies Demonstrated ability in analytical reasoning and critical thinking skills. Ability to contribute and lead a team environment. Ability to understand and apply business drivers outside of Regulatory Affairs. Strong communication skills, both oral and written. Strong interpersonal skills with the ability to influence others in a positive and effective manner. Detail‑oriented with the ability to proofread and check documents for accuracy and inconsistencies; able to do so quickly without sacrificing attention to detail. Bachelor's degree or higher preferred. In lieu of a degree, 8 years industry experience with applied knowledge of applicable standards and regulations of medical device labeling requirements. #J-18808-Ljbffr Spectraforce Technologies