Specialist Labeling & Technical Documentation (m/f/d)

☞ LivaNova

看过: 115

更新日: 07-10-2024

位置: Munich Bavaria

类别: R & D 咨询/客户服务

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工作内容

Join us today and make a difference in people’s lives!

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-Artmedical 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
If you like the sound of the above and feel energised by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
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.
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:
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.
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最后期限: 21-11-2024

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