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6 days old

Documentation Specialist

Kelly Services
Raynham, MA 02767
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Documentation Specialist for a long-term engagement at one of our Global clients in Raynham, MA. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. KellyOCG employees receive annual performance reviews.

Job Title: MDR IFU Coordinator


1. Job purpose:

To assist with the EUMDR change project by verifying initial records, effecting change, and maintaining compliance of Instructions for Use (IFUs) to enable correct and timely regulatory EUMDR submissions and enable on-time delivery of new documents.

2. Principal Accountabilities:

? Route initial changes through Adaptiv/PLM system.

? Send changes to layout/translation vendor for new artwork

? Track all changes and report project status to team

? Work with RA team to ensure IFU changes are complete for required submissions

? Receive and proof all changed artwork. Will be using Docu-Proof software with some visual proofreading, and visual checking of graphics/symbols/logos

? Re-route all changes through Adaptiv/PLM for final approval

? Communicate changes to Distribution Center and upload IFU artwork to SharePoint for Supply Chain

? Upload eIFUs to url

? Perform miscellaneous tasks as needed such as file transfers to printer, interaction with layout/translation vendor, communication with other stakeholders

? Attend project meetings as required


3. Dimensions: No direct reports.


5. Internal And External Relationships

Reports directly to Customer Regulatory Associate

Co-ordinates appropriate activities through the Cerenovus EUMDR and Regulatory Affairs teams

Maintains strong relationships with Regulatory Affairs and EUMDR project team


6. Qualifications And Experience

Basic understanding of compliance and regulatory requirements is not a requirement but is

preferred.

Flexibility able to adapt to compliance cycle activities and demanding timelines

Excellent written and verbal communication, and the ability communicate effectively with all

levels of the organization

Must possess skills in the areas of attention to detail and excellent time management

Ability to handle a large number of subparts simultaneously

Must be comfortable working independently.

Ability to work well with others


7. Special Aptitudes:

Excellent Adaptiv knowledge and skills

Excellent PC skills (Microsoft Word, Adobe Distiller).

Strong Organization Skills


8. Competencies:

SPECIFIC COMPETENCIES

Excellent planning and organizational skills.

Time management.

Communication listener, learner and thinker.

Thorough and flexible.

Cross culturally aware.

Team player

Enthusiastic and committed.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-10-11 Expires: 2021-11-11

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Documentation Specialist

Kelly Services
Raynham, MA 02767

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