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1+ months

Regulatory Affairs Labeling Specialist

Kelly Services
St Louis, MO 63112
A client of Kelly Services in the Life Sciences industry seeks a Graphic Design Regulatory Affairs Specialist for a long-term fulltime remote project.


Hours per week: 40


Length of contract: 1-2 years


Hourly Pay Rate: $50


**_Job Description_**


Global Labeling Lead 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.


**_Daily Responsibilties_**


+ 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 redline 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


**_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 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


**Why Kelly** **** **?**


Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-04-15 Expires: 2022-06-20

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Regulatory Affairs Labeling Specialist

Kelly Services
St Louis, MO 63112

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