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LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol "LIVN". LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.
RESPONSIBILITY AND AUTHORITY
This position is responsible for the development, implementation, and maintenance of package labels and product labeling (physician and patient) for Neuromodulation Business Unit products. This position reports to the Manager, Clinical Engineering, and Labeling.
Primary Activities
1. Develops and provides labeling implementation plans for the timely implementation and release of product and package labeling throughout all Quality System documentation (e.g., IFUs, assembly documents, DMRs) in support of new product development or sustaining engineering programs.
2. Creates and maintains product labeling content (e.g., instructions for use, software product UI) per system and sub-system requirements.
3. Develops, executes, and maintains the management of software product UI, including localization of the UI.
4. Creates and manages package label content and physical package label design, including the associated specifications per system and sub-system requirements.
5. Coordinates with Procurement in the identification of and communication with suppliers for externally printed labels and product labeling.
6. Reviews software product UI, product and package labeling for completeness and accuracy.
7. Works with localization vendors to manage the translation and localization of product software UI, and product and package labeling.
8. Engages with cross-functional project team during the design input and product development phases to ensure the product architecture supports localization (including localized UI for software products) and working with the development team in implementing designs that support localization.
9. Coordinates the implementation of package labels with Operations and IT, using current ERP and label printing systems.
10. Creates test cases, executes and documents results of labeling verification for new and revised product and package labeling content.
11. Maintains DI / GTIN assignments for supported software product and package labeling.
12. Coordinates / performs web posting of approved labeling.
13. Identifies applicable labeling requirements from the global Labeling requirements, or as applicable from regulations or standards, for new or revised products.
14. Supports Quality System and Regulatory audits for the Labeling function.
Minimum Requirements And Qualifications
1. 3-5 years of experience with Class III Medical Device Labeling or product localization for medical device or consumer devices.
2. Proficient in visual design of package labels using symbols and information from FDA recognized consensus standards and international standards.
3. Familiarity with labeling and product localization in a regulated environment.
4. Experience with one or more of the following software programs: Loftware or NiceLabel, MadCap product suite, and Adobe InDesign and Illustrator.
5. Experience with an electronic document management system (e.g. SmartSolve).
6. Bachelor’s degree in communications, technical writing, biomedical engineering, biomedical communications, human factors engineering, or related discipline.
Additional Information
1. Pay Transparency: The target salary range for this position is $80,000 - $100,000 annual salary, plus discretionary annual bonus. Pay ranges will be granted based on experience of the selected candidate.
2. Worksite Schedule: This will be a hybrid schedule with 3 days onsite and 2 work from home days per week.
Employee Benefits Include
1. Health benefits – Medical, Dental, Vision.
2. Personal and Vacation Time.
3. Retirement & Savings Plan (401K).
4. Employee Stock Purchase Plan.
5. Training & Education Assistance.
6. Bonus Referral Program.
7. Service Awards.
8. Employee Recognition Program.
9. Flexible Work Schedules.
Our Commitment To Diversity & Inclusion
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Notice To Third Party Agencies
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Beware Of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.
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