Hillrom is a $2.8B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.
Description New requirements and processes were put in place during EU MDR remediation. These requirements and processes need to be maintained and supported by the local Acton site.
Position will combine Training/Document Control role with these new requirements to create a more robust and needed role.

Technical File Maintenance (20% of role)
* Maintain technical documentation for CE Mark and any identified updates required. Collect and review all technical documentation, coordinate with subject matter experts, and process updates in electronic data storage systems. This work may include creating new technical documentation (Technical documents required for CE marking) or updating existing ones.

* Update risk files as needed due to customer complaints.

* Coordinate and conduct Annual Risk Management Reviews for all product in Allen portfolio.

* Support new product release requirements.

* Declaration of Conformity (DoC) maintenance, updates, and translations.

* Electronic Summary Technical Documentation (eSTED) and General Safety and Performance Requirements (GSPR) maintenance and updates.

* Support external requests for technical documentation.

Instructions for Use (IFU) Maintenance, updates & Translations (10% of role)
* Maintain and revise current IFUs for updates.

* Update IFUs as required to maintain compliance to EUMDR. Collect information and contribute to redlines on existing IFUs or in the drafting and creation of new IFUs in partnership with Engineering and Clinical subject matter experts.

* Updates will require knowledge and understanding of existing regulations, combined with technical knowledge provided by Clinical and Engineering subject matter experts.

* Support new effort to make the IFUs available on the website and ensure the website is updated as new revisions of the IFU are released.

* Coordinate with marketing for new country releases and IFU translations needed. Schedule meetings, coordinate redlines across multiple subject matter experts, submit change requests for approvals. May be required to explain changes required to marketing teams, based on knowledge of regulatory standards.

* Requires understanding of regulations but does not require detailed knowledge or understanding of specific IFU content, as that will be provided by subject matter experts.

CEOT (Central Economic Operator Team) Support (10% of role) * Support CEOT checklist (EUMDR Checklist) of all products being sold into Europe,

* Remediate gaps found by CEOT group by collecting data from, scheduling meetings with, and coordinating redlines of documents or creation of new documents, from relevant subject matter experts to update documents and/or gather new information as required.

* Ongoing support for Allen products sold into Europe, including all information required is clearly communicated and updated with our Authorized Representative and EU Importer. Will required knowledge of existing regulations and coordination with multiple subject matter expert groups.

* Support CEOT group on new product launches, including collecting and drafting required technical documents, in partnership with Engineering, Marketing, and Clinical subject matter experts.

PMS/CER/Risk Management Update Support (10% of role)
* Support Post Market Surveillance and Clinical Evaluation Reporting groups on creating PMS reports from scratch on a staggered schedule every 4 years.

* Support PMS/CER group with updates to10 CERs (Clinical Evaluation Reports) on a staggered schedule every 4 years. Updates will require retrieving and delivering the correct technical documentation from each 10 technical files to support the information updated in the CER.

* Coordinate Risk file updates once PMS Report and CERs are updated. This shall entail creating new Risk Management Reviews for all products in all technical files. Risk files may possibly be updated including but not limited to Risk, Analysis & Controls (RA&C), Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA) and Risk Management Reports (RMR) to include customer misuse scenarios and design flaws discovered during post market surveillance review.

* Revise Instruction for Use (IFU) with any finding from PMS/CER/Risk file updates. This shall include but limited to additional warnings & cautions required to address issues uncovered during post market surveillance research.

REACH/RoHS Maintenance (20% of role)
* Continue efforts to collect REACH/RoHS component certifications for evidence of compliance and collect certifications for all new components, maintain GreenSoft database. This entails contacting suppliers to obtain certifications, searching through incoming inspection files, and using judgement when supplier do not respond to find Material Safety Data Sheets (MSDS) or using component equivalence to show material compliance.

* Maintain current knowledge of REACH/RoHS requirements and changes to inform Engineering subject matter experts and drive updates as required.

* Gather Bill of Materials (BOMs), documents and information from Operations and Engineering to provide updated information and input into Greensoft for database maintenance.

* Run REACH/RoHS compliance report from GrrenSoft Database for each product in Allen Portfolio.

Site Training Administrator (15% of role)
* Responsible for ensuring site-wide training compliance. This includes daily interaction with the production floor, manual training record execution and uploading etc.

* LMS administration.

* Daily/weekly training reporting and tracking.

* Manage (maintain, update) all curricula for the site.

* Interact as part of the global community of training administrators.

* Work with site QMS owner to ensure that the site entity matrix is accurate, and that all items on the matrix are accounted for in site/corporate curricula, and that all documents in site/corporate curricula are accounted for on the site entity matrix.

Site Document Control Coordinator (15% of role)
* Responsible for all paper record storage, organization, and retrieval on and off site (Iron Mountain).

* Ensure that all corporate document changes are appropriately communicated to the site level document owners, and track change control to ensure that site and corporate procedures maintain alignment.

* Facilitate and execute all document change requests through local and corporate (DCSS) processes. Support all site employees with changes (i.e. document updates) and change process.

Qualifications EDUCATION AND EXPERIENCE
Bachelor's degree required in any discipline, but preferred background in Engineering, Regulatory Compliance, or Quality Systems.
Position requires higher level analysis and critical thinking, as well as knowledge/experience in dealing with ... To view the rest of this job posting or to apply for this position please click the APPLY NOW button