Regulatory Labelling Associate

Labeling Specialist page is loaded## Labeling Specialistlocations: Palm Harbor, FLtime type: Full timeposted on: Posted Todayjob requisition id: R34212By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.**Customer**We focus on our customers’ success**Innovation**We create better solutions**Collaboration**We create success together**Inclusion**We always interact with others respectfully**Candor**We are open and honest with one another**Integrity**We do the right things and do things right**Accountabilities & Responsibilities:*** Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.* Review labeling documents to ensure that formatting of text and graphics conform to established guidelines for consistency, technical construction, and overall presentation.* Tracks and maintains labeling documents using process tools for revision control.* Prepares and manages labeling translations activities.* Review and approve vendor proofs.* Perform upload and maintain the FDA UDI GUDID database.* Initiate and/or implement Change Control Requests pertaining to labeling updates.* Follow through on open Change Control Requests and evaluate the impact assessment related to labeling updates.* Strive for continuous improvement and consistency in deliverables.* Communicates with internal and external customers regarding ongoing labeling updates.* Ensure labeling are up to date and accurate.* Collaborate with cross-functional teams to ensure labeling deliverables are on-track with each project.* Provides support with internal and external Regulatory submission package.* Provide support to labeling projects for new product development and current production.* Collaborate with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.* Support the execution of Label Validation Plans and Reports as needed.* Ensure labeling is compliant with regulatory, customer and specification requirements and standards.* Provide technical support for label printing and database management.* Performs other duties as required.**Education & Experience:****Minimum Education & Experience:*** A minimum of three 3 years of experience of GMP, FDA, Change Control process* General understanding of U.S. FDA UDI and EU MDR labeling requirements**Knowledge & Skills:*** Strong attention to detail. Experienced with Microsoft Office.* Strong organizational and time management abilities* Strong proficiency with Adobe InDesign* Proficiency with Adobe Illustrator* Knowledge of label creation softwareOur total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base wages, a cash-based incentive program supporting our pay-for-performance philosophy, overtime pay, shift differentials, and call-in pay, when applicable. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.**U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.**Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical and Lake Region Medical. Additional information is available at .Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via View email address on click.appcast.io so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in toFor remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.**To review the Integer U.S. Applicant Privacy Statement click****.** #J-18808-Ljbffr Integer Holdings Corporation