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Labeling Specialist, Regulatory Affairs

Req ID:  2521

Working Location: MINNESOTA, BROOKLYN PARK; MASSACHUSETTS, WESTBOROUGH 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

Support and participate in the creation, editing, processing, and translation of labels and IFUs. Ensure the regulatory compliance of labeling materials including labels and instructions for use (IFUs), and other materials.

Ensure compliance with UDI requirements. Support the completion of corrective actions and the addressing of internal and external audit findings. Provide support during third-party and regulatory audits.

Job Duties

* Develop, edit, review, and process changes to labeling materials to ensure that Gyrus ACMI is in compliance with all federal, state, and international labeling requirements. Labeling materials include labels and instructions for use (IFU).

* Provide input and advice for labeling matters including assessment of regulatory requirements, labeling procedure requirements, and labeling infrastructure.

* Carry out activities to ensure compliance with UDI requirements.

* Follow up resolution of internal audit findings and external audit findings through the Gyrus ACMI Corrective and Preventive Action program.

* Assist in responding to regulatory inspections by regulatory agencies.

* Support manufacturing, engineering, quality assurance, product development, and clinical affairs as required to ensure regulatory compliance.

* Assist with the development of quality system procedures as they relate to labeling.

Job Requirements

REQUIRED QUALIFICATIONS: 

* Bachelor's Degree preferred, preferably in graphic design, packaging engineering, regulatory affairs, related life sciences field, or comparable experience in the Medical Device Industry (2 years preferred).

 

* Experience or knowledge of medical device labeling development (labels and/or IFUs).

 

* Documented continuing education in regulatory affairs or RAC certification is a plus.

 

*· Must be able to occasionally travel to Olympus/OSTA facilities in the U.S.

 

PREFERRED QUALIFICATIONS:

* Graphic design and development experience is preferred.

 

* Knowledge of ISO 13485/QSR requirements is preferred.

 

* Knowledge of ISO 15223 requirements is preferred.

 

* Proficiency in Microsoft Office (Word, Excel or Access, PowerPoint) is preferred.

 

* Proficiency in Adobe Illustrator, InDesign, and/or Framemaker is preferred.

 

* Proficiency in labeling software systems (LabelView, Loftware, Prisym, Label, Robar, etc.) is a plus.

 

* Proficiency with thermal transfer label printers (Zebra, SATO,DataMax) is a plus.

 

* Other Considerations (travel/hours availability, etc.):

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || 


Nearest Major Market: Minneapolis

Job Segment: Engineer, QA, Quality Assurance, Manufacturing Engineer, Engineering, Quality, Technology

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