**Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity, and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.**About the role**:
Under moderate supervision/guidance, brings clarity and consistency to Labeling deliverables (Instructions for Use and Product Information for Patients) through accurate and concise writing and effective use of English according to the technical/educational level of the end user. Collaborates with other functions (R&D, Design Assurance, Clinical, Medical, Regulatory Affairs, etc.) to ensure Labeling content is developed per, and compliant to, all applicable procedures, standards, and regulations.
**Your responsibilities include**:
- Developing Labeling Deliverables: The primary responsibility would be to develop labeling deliverables, including Instructions for Use (IFUs) and Product Information for Patients, ensuring clarity and consistency in the content. This involves accurately translating technical information into language that is understandable for the end user.
- Writing and Editing: The individual would be responsible for writing and editing labeling content to ensure it is accurate, concise, and effectively communicates the necessary information to the intended audience. This includes reviewing and revising content as needed to improve clarity and readability.
- Ensuring Compliance: Compliance with regulatory requirements and internal standards is crucial in labeling. The individual would need to ensure that labeling content is developed and maintained in accordance with all applicable procedures, standards, and regulations. This may involve collaborating with regulatory affairs professionals to stay updated on regulatory changes and requirements.
- Collaboration: Collaboration with other functions within the organization is essential to ensure that labeling content meets all requirements and is aligned with product specifications. The individual would collaborate with teams such as R&D, Design Assurance, Clinical, Medical, and Regulatory Affairs to gather necessary information and ensure accuracy and consistency in labeling deliverables.
- Adhering to Procedures: Following established procedures and workflows is important to maintain consistency and quality in labeling deliverables. The individual would need to adhere to company procedures and guidelines for developing, reviewing, and approving labeling content.
- Quality Assurance: Ensuring the quality of labeling content is another key responsibility. This involves conducting thorough reviews of labeling deliverables to identify and correct any errors or inconsistencies. Attention to detail is crucial to maintain the accuracy and integrity of the content.
- Continuous Improvement: Striving for continuous improvement in labeling processes and content is important to enhance clarity, effectiveness, and compliance. The individual would be responsible for identifying areas for improvement and implementing changes as needed to optimize labeling deliverables.
**What we are looking for**:
- Studies completed in English, English Teaching, Translation or applicable field (bachelor's degree or higher).
- English Level desired: C1 (90%) or above.
- Quality System requirements: In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Desired knowledge: Functional Knowledge, Business Expertise, Problem Solving, Leadership, Impact, Interactions & Communications.
- Regulatory Affairs: professionals with experience in regulatory affairs, especially those with knowledge of labeling regulations and guidelines specific to the medical devices industry.
- Medical Writing: individuals with a background in medical writing, particularly those with experience in creating patient-facing materials such as Instructions for Use (IFUs) and Product Information for Patients (also known as Patient Information Leaflets). Individuals shall be familiar with translating complex med