Specialist Labeling

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Specialist Labeling & Technical Documentation (M/F/d)

General Responsibilities
- Coordinate the creation of labeling material (product labels, instructions for use. etc.)
- Analyse relevant standards, regulations/directives, guidance documents, etc. and derive labeling requirements satisfying the regulatory requirements of international markets; or willingness to develop such skills on the job.
- Support in the migration to a new state-of-the art global enterprise label management system
- Coordinate labeling efforts with other departments involved, such as regulatory affairs, production/operations, logistics, customer service, and others
- Coordinate and drive external vendors, such as agencies for translation and technical writing services in order to deliver high-quality technical publications (mostly instructions for use).
- Draft and raise change requests and coordinate with relevant stakeholders and action item owners, driving changes from planning phase to closure in an effective manner.
- Order placement (translation and technical writing projects)

Skills and Experience
- BA/BS in relevant disciplines, such as technical communication, technical writing & translation, engineering, or related field with some years of experience
- English excellent spoken and written
- Strong writing, editing and verbal abilities, as well as technical communication capabilities
- Proven technical understanding acquired though education and/or on the job
- Experience working in a highly
- regulated environment, (ideally in MedTech, but also biotech, pharma, etc.) highly desirable
- Ability to drive results in a fast-paced and agile work environment
- Structured and detail-oriented work approach
- Ideally knowledge of the requirements of the Medical Device Regulation (MDR), especially regarding labeling/accompanying documentation, instructions for use, and proven experience in implementing these
- Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.
- Willingness to develop processes through standardization, continuous improvement and digitization & automation
- Document management in our electronic document management system, maintenance of eIFU website
- Experience working with modular documentation in a content management system (Schema ST4, or similar) is a plus

What we can offer you

In addition to providing, you with a supportive, inclusive, and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a _State-of-the-Art _medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognise and celebrate our colleagues’ contributions and achievements

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._

Background Checks at LivaNova:

- Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check._

Notice to third party agencies: