10 Labeling Specialist II Jobs in Portsmouth, NH
SORT BY
U
U
U
L
L
L
S
S
T
N
Labeling Specialist II
$81k-105k (estimate)
Full Time
1 Week Ago
Laborie Medical Technologies is Hiring a Labeling Specialist II Near Portsmouth, NH
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values ofAspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
The Labeling Specialist II is a Subject Matter Expert (SME) responsible for managing device labeling (including, but not limited to labels, IFUs, and UDI) as necessary to market our medical devices worldwide.
About the Role:
- Review product specifications and other regulatory documentation to ensure label compliance. Review promotional material for compliance with application regulations and product claims.
- Review labeling to ensure content is accurate and current. Investigate any label discrepancies, missing documentation and inaccuracies as part of the change control for global products, by ensuring labeling compliance with the applicable medical device and food regulations.
- Maintain highly collaborative relationship with other internal groups.
- Preparation/creation of Change Plans for ensuring that finalized labeling is entered into the Document Control System and implemented into the product.
- Liaison with Regulatory, Marketing, Operations and Sales of and manage changing properties to support label channel e projects including launches, promotions and packaging update.
- Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits.
Minimum Qualifications:
- Bachelor’s Degree with at least 5-8 years of related Regulatory experience, mostly in medical devices; 3 years’ experience in a Regulatory Affairs leadership role preferred.
- Excellent understanding and demonstrated leadership of label development, IFU development, change management systems, and global labeling regulations, requirements, procedures, and concepts. In addition, willingness to learn and stay informed of labeling regulations.
- Extensive knowledge of global medical device regulations and standards, such as, but not limited to FDA, MDD, EU MDR, Health Canada, Australia, Japan etc,
- Excellent oral and written communication skills, ability to multitask and work in multi-disciplined teams, and strong attention to detail, written and oral communication, teamwork, and organization skills.
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
Laborieprovidesequal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexualorientation,or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
Job Summary
JOB TYPE
Full Time
SALARY
$81k-105k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
08/22/2024
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
