Find & Apply For Regulatory Affairs Specialist Jobs in Mentor, Ohio

Product Labeling Specialist Brooksource - 3.7 Mentor, OH Job Details Full-time | Contract $35 - $40 an hour 3 days ago Benefits Health insurance Dental insurance Vision insurance Qualifications Technical editing Content creation for technical audiences Labeling Technical writing experience within manufacturing Process improvement Bachelor's degree Attention to detail Adaptability Communications Biomedical regulatory compliance Regulatory compliance analysis Legal compliance Cross-functional communication

Full Job Description Product Labeling Specialist Location:

Mentor, OH Compensation:

$35-$40/hr

Position Type:

Contract-to Hire Job Summary The Product Labeling Specialist works within Product Engineering and is responsible for the design and development, approval, and implementation of product labelling on new and sustaining projects. The labeling function will be required to interface with domestic and international Regulatory Affairs, Quality, Product Managers, New Product Development, Clinical Affairs, Purchasing, Manufacturing/Production, Information Technology, and Packaging Engineering and will be responsible for labelling implementation. The position will work closely with Regulatory Affairs to ensure compliance with domestic and international regulations. Additionally, the position includes working with multiple vendors (including translation services and print suppliers) and program management for all labelling projects. Key Responsibilities

• Creates and modifies labels, product instruction for use (IFU) documents, label cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines, and branding guidelines.
• Drives numerous product labeling project tasks that culminate in release to production via the engineering change process.
• Leads activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process
• Ensures that labeling meets all medical, legal, and regulatory requirements.
• Confers with label change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective, and timely manner
• Works with IT, manufacturing, and document control personnel to set label printer parameters. Works with this same team to troubleshoot issues and establish processes that eliminate issues.
• Contributes to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvements, country-specific requirements, labeling standards and regulations, and labeling stakeholders.
• Interfaces with other Labeling Specialists to ensure processes and requirements are aligned.
• Works with outside vendors on content translations for labels and IFUs.
• Demonstrates expertise of clients products and technologies, product labeling, and engineering change processes. Required Qualifications
• Bachelor's degree in a Science, Communications, or related field preferred.
• 2+ years of product labeling experience within the medical device industry or another regulated environment.
• 1 year of experience working with regulatory requirements and regulated documentation.
• Strong technical writing skills, including product labeling development and documentation within a regulated industry.
• Knowledge of medical device regulations, standards, and labeling requirements.
• Ability to work independently with limited supervision and make sound decisions based on analysis.
• Customer-focused mindset with the ability to build effective cross-functional relationships.
• Excellent written and verbal communication, copy editing, and documentation skills.
• Exceptional attention to detail and commitment to accuracy.
• Flexible and adaptable, with the ability to manage changing priorities, deadlines, and project needs. Preferred Qualifications
• Minimum 1 year of experience using content management systems; experience with NiceLabel/Loftware or NiceLabel/Loftware Cloud preferred.
• Experience with document management and Product Lifecycle Management (PLM) systems.

ABOUT US

At Brooksource, relationships are the foundation of everything we do. Since 2000, we've built lasting partnerships with clients, consultants, and internal teams to deliver an exceptional experience across every engagement. As a trusted IT and Engineering services provider, Brooksource supports Fortune 500 organizations through Experience-Driven Staffing, Professional Services, and Elevate, our proprietary Workforce Transformation program. We offer flexible hiring models and are a certified partner of leading platforms, including Salesforce, AWS, Microsoft, and Google Cloud, enabling us to deliver scalable, end-to-end technology solutions.

EEO STATEMENT

Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

PAY DISCLAIMER

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Pay:

$35.00 - $40.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person