Regulatory Affairs Specialist

Description:

This individual 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, involved in the development of labeling processes and procedures to enhance existing practices.

• Manage and coordinate labeling change requests and content updates for US only artwork, MDD, MDR, new product launches, private label or regional/country specific (lens/lens care).
• Work with regional/country requestors 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
• Works to resolve any conflicts of reviewer feedback on labeling content
• Work closely with LRS Coordinator to align & interpret LRS into a red line versions of artwork
• Provides continuous feedback to LRS Coordinator on any content changes that would impact LRS updates
• Sit in on LRS meetings with LRS Coordinator
• Act as LRS Coordinator back-up
• Redline and communicate changes with project team and disseminate information to Graphics team for artwork creation
• Perform all assigned ELM project tasks
• Submission artwork support
• Provides RA artwork support for health authority submissions (provides before/after
• artworks, redlined PDFs, etc.)
• Monitors timelines and advises project teams of any impacts to timelines during TG1
• SOP support/review
• Participate in company audits, as needed
• Other job responsibilities as needed

• 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.

• Demonstrated ability in analytical reasoning and critical thinking skills
• Ability 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 degree, 8 years industry experience with applied knowledge of applicable standards, regulations of medical device labeling requirements.

Requirements What happens next

Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

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