Senior Labelling Specialist

The Senior Labelling Specialist plays a vital role in the development and maintenance of product labeling, ensuring compliance with global regulations and company standards. This position is responsible for the creation, review, and approval of labels and other product packaging materials, ensuring accuracy, clarity, and alignment with marketing and legal requirements. Key responsibilities include:

• Developing and approving labeling content in accordance with regulatory requirements and internal guidelines.
• Collaborating with cross-functional teams including Regulatory Affairs, Quality Assurance, and Marketing to ensure labeling accuracy and effectiveness.
• Managing the labeling change control process, including the documentation and implementation of changes.
• Conducting risk assessments related to labeling and packaging to ensure product safety and compliance.
• Staying updated on industry trends and regulatory changes affecting labeling requirements.
• Providing training and guidance to junior labeling specialists and other team members on labeling best practices and regulatory compliance.

Requirements

• Bachelor's degree in a relevant field such as supply chain/logistics, engineering, business or related disciplines.
• Minimum of 5 years of experience in labeling, regulatory affairs, or a related field within the medical device or pharmaceutical industry.
• Strong understanding of global labeling regulations including FDA, EU MDR, and ISO standards.
• Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely.
• Proficient in project management and able to manage multiple tasks simultaneously.
• Attention to detail and strong analytical skills to evaluate labeling information effectively.
• Experience with label management software and documentation systems.

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

· Employer subsidized health insurance for employees

· Employer paid dental insurance

· Employer HSA contribution

· 401k plan with a company match

· 9 paid holidays (including your birthday!) + PTO and Personal days

· Gym membership subsidy

· Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Salary Range: $80,000-$125,000