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18 days old

Sr. RA Labeling Specialist

Kelly Services
Clearwater, FL 33765
Kelly Services is actively looking for a Sr. RA Labeling Specialist opportunity located in Clearwater, FL. This position does have potential to go permanent after a year.


Pay rate: $50 - $70/hour


Duties:

Leads labeling artwork projects for the development of new and changes to existing product labeling components (including package inserts, medication guides, patient/pharmacist information inserts, directions for use, instructions for use, container labels, and cartons, etc.)

Provides labeling component artwork files to support initial submissions and post approval labeling changes

Evaluates content of labeling on all labeling component artwork to ensure compliance with regulatory requirements and company guidelines (Branding, Trademarks

Collaborates and facilitates review and approval processes with appropriate cross functional teams (such as Regulatory Affairs Product Lead, Manufacturing, Change, Control RA, Graphics, Legal, Quality, Supply Chain, Marketing, R&D, Engineering) and external parties to develop new or update existing labeling component artwork

Monitors, evaluates and recommends improvements to labeling process, systems, tools and/or procedures.

Participates in global labeling projects, ensuring accuracy of all labeling components as well as timeliness of projects to meet all commitments and deadlines.


TECHNICAL COMPETENCIES:

Knowledge of medical device regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations.

Knowledge of EU Medical Device and FDA regulations relating to submissions and regulatory approval of medical devices.

Knowledge of medical device 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

Qualifications:

5+ years relevant medical device and regulatory experience with at least 2 + years of medical device labeling experiences,

Bachelors degree or higher,

Applied knowledge of European (MDD and MDR) and US FDA labeling requirements, Familiarity with XML concepts including structured product labels (SPLs) preferred.



For immediate consideration, please apply online. #TJP2021_PNI


**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: 2021-04-23 Expires: 2021-05-24

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Sr. RA Labeling Specialist

Kelly Services
Clearwater, FL 33765

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