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Senior Lead Labeling Specialist
2 months ago
We are seeking a highly skilled Senior Lead Labeling Specialist to join our team at MicroVention-Terumo. As a key member of our labeling operations team, you will be responsible for leading cross-functional project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards.
Key Responsibilities- Lead Labeling Operations: Oversee end-to-end labeling activities for multiple projects from initiation to product launch, ensuring timely delivery of draft labels for submissions and release of finished labels into production.
- Collaborate with Cross-Functional Teams: Work closely with Marketing, R&D, Regulatory Affairs, and Legal to develop labels that meet the needs of customers and all regional regulatory requirements.
- Develop and Implement Labeling Strategies: Plan and execute label development schedule, ensuring compliance with company policies and procedures, and collaborating with the Labeling Design team to ensure labeling requests are completed accurately and promptly.
- Ensure Regulatory Compliance: Ensure all labeling changes comply with applicable laws and regulations, and adhere to Quality Management System processes and requirements.
- Manage Project Tracker and Communication: Update project tracker and proactively communicate any delays or scope changes to stakeholders.
- Perform Additional Duties: Perform additional duties as assigned by management.
- Education and Experience: Bachelor's degree or equivalent combination of education and experience, with a minimum of five years of relevant experience in product labeling in the medical device field.
- Project Management Experience: Minimum one year of experience in project management in a related field.
- Labeling Design and Development Skills: Ability to design and modify labels, IFUs, and Patient Implant Cards.
- Regulatory Knowledge: In-depth knowledge of relevant labeling standards, including 21 CFR 801 – Labeling, 21 CFR 820 – Device Labeling, 21 CFR 830 – Unique Device Identification, FDA, ISO 15223, CDRH Guidance Document, etc.
- Communication and Team Leadership Skills: Excellent written and verbal communication skills, and ability to work effectively and confidently in a team environment.
- Competitive Salary and Benefits: Medical, Dental, Vision, and 401(k) with Company Match.
- Casual Work Environment: Work in a dynamic and collaborative environment with a talented team of professionals.
- Talent Development Program: Opportunities for professional growth and development through training and mentorship.
- On-site Gym and Exercise Room: Stay healthy and active with our on-site fitness facilities.
- Employee Referral Program: Earn rewards for referring friends and colleagues to join our team.
- PTO and Paid Holidays: Enjoy a generous PTO policy and 15 paid holidays per year.
- Tuition Reimbursement: Up to $10,000 per year for education and training expenses.
- LinkedIn Learning Courses: Access to a wide range of online courses and training resources.
