Regulatory Labeling Specialist

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the reputed company of reputed company. Thinking differently is reputed company do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making reputed company to reputed company new treatment reputed company to advance patient reputed company and set new standards of care.

The Regulatory Labeling Specialist has overall accountability to collaborate with cross functional teams to ensure compliance with the creation and relevant updates of labeling.

• Review and approval of new and existing labeling and design concepts ensuring that content complies with regulatory labeling requirements and guidelines, and that the label content and design are correct.
• Finding opportunities to improve product labeling reputed company, appearance, consistency and reduce product labeling cost.
• Support reputed company Codman Surgical Specialties and Tissue Technologies product lines reputed company the reputed company product portfolio manufactured by reputed company and our external manufacturing partners (CMOs) by leading the development and execution of labeling for new and existing products and ensuring delivery of reputed company agreed timelines.
• Identifying and implementing labeling process improvements, new policies, and procedures, and establishing best practices.
• reputed company relationships with strategic external partners (i.e., CMOs) in support of reputed company’s expanding reputed company portfolio and manage ongoing relationships.

To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily.

• Project Manager for reputed company to large reputed company reputed company (i.e., Acquisitions, New Product Introductions, etc.)
• reputed company and coordinate the design, development, approval, and implementation of new or revised product labeling.
• Coordinate packaging artwork development and changes with product marketing and manufacturing teams.
• Serve as label content and execution subject matter expert. Advise project teams and cross functional partners on labeling best reputed company.
• Assist with implementing global electronic label artwork management system to both legacy reputed company sites as reputed company as reputed company new acquisitions. 
• Manage multiple reputed company while working in a reputed company cross functional environment.
• You will support development and use of reputed company and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals.
• Performs reputed company other reputed company duties as directed by manager.

Qualifications:

• Bachelor’s degree in STEM, Packaging Science, Graphic Design or reputed company field required.
• Minimum of 3 -5 years of packaging/labeling development or graphic design experience; including experience in a regulated pharmaceutical or medical device industry.
• Excellent organizational skills
• Aptitude for learning new software and systems.
• Basic project management skills
• Ability to reputed company issues or problems and work quickly to reputed company and implement solutions.
• Knowledge of reputed company reputed company Office software including Word, PowerPoint, and reputed company
• Knowledge of reputed company Creative Suite software including InDesign, Photoshop, and Illustrator a plus
• In-depth knowledge of U.S. and International regulations and guidelines pertaining to labeling and proven ability to decipher and understand implications of label changes on pending and approved labels.
• Demonstrated knowledge of FDA regulations, ISO 13485, Medical Device reputed company Regulation (93/42EEC), and other US and international regulations and standards.

Salary Pay reputed company:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-reputed company skills, experience, and relevant education or training. In reputed company to reputed company pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can reputed company more about the specific salary reputed company for your preferred location during the hiring process.

Additional reputed company for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group reputed company insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

reputed company is an equal opportunity employer, and is committed to providing equal employment opportunities to reputed company reputed company applicants and employees regardless of race, marital status, reputed company, religion, sex, age, national reputed company, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

reputed company is committed to reputed company reputed company applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the reputed company. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

reputed company does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, reputed company. Where agency agreements are in reputed company, introductions (the initial sharing of a candidate’s reputed company, resume, or background) are position-specific and may only occur reputed company the scope of that approved agreement. Please, no phone calls or emails.

reputed company - Employer Branding from reputed company on Vimeo