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. We’re currently looking for a Labeling Specialist, Regulatory Affairs to join us in the Southborough, MA area.
Let’s inspire healthier lives, together.
The Labeling Specialist, Regulatory Affairs ensures the regulatory compliance of labeling materials, including labels, instructions for use and other materials. He/ She ensures compliance with UDI requirements. The incumbent supports and participates in the creation, editing and processing of Instruction for Use (IFUs) and their translations. He/ She supports the internal audit program by conducting or facilitating audits. He/ She supports the completion of corrective actions and the addressing of internal and external audit findings. The incumbent provides support during third- party and regulatory audits.
As a Labeling Specialist, Regulatory Affairs working on the RA/QA Technical Communications team, you will be empowered and inspired to do your best work. You will contribute to our mission by exemplifying integrity, agility, unity, empathy, and long-term view. In a typical day, you will:
* Provide input and advice for labeling matters including assessment of regulatory requirements, labeling procedure requirements, and labeling infrastructure.
* Review and develop labeling materials to ensure that Gyrus ACMI is in compliance with all federal, state, and international labeling requirements. Labeling materials include labels, IFUs, promotional brochures, sales training materials, and labeling information posted on company websites (internal and external facing).
* Carry out activities to ensure compliance with UDI requirements.
* Execute the label and IFU functions including the creation, editing, and processing of labeling changes.
* Follow up resolution of internal audit findings and external audit findings through the Gyrus ACMI Corrective and Preventive Action program.
* Attend regulatory inspections by regulatory agencies and assist in responding to them.
* Support manufacturing, engineering, quality assurance, product development, and clinical affairs as required to ensure regulatory compliance.
* Conduct and report internal audits as scheduled in accordance with QSR, CFR, CE/EN, and other relevant standards.
* Assist with the development of quality system procedures as they relate to labeling.
* Perform other duties as assigned.
* Knowledge of ISO 13485/QSR requirements is required.
* Knowledge of ISO 15223 requirements is required.
* Must be able to occasionally travel to Olympus/OSTA facilities in the U.S.A.
* Bachelor degree preferred, preferably in engineering, life sciences or STEM related field, or comparable experience in Medical Device Industry (2 years preferred).
* Ability to work in a small team environment, but also a self- starter with the ability to work independently.
* Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
* Must be able to meet deadlines and be detailed orientated.
* Good planning and organization skills are a must.
* Strong critical thinking and problem solving skills.
* Must be able to communicate effectively (verbal and written).
* Experience or knowledge of medical device labeling development (labels and/or IFUs).
* Must be proficient in Microsoft Office (Word, Excel or Access, PowerPoint).
* Proficiency in Adobe Illustrator, InDesign, and Framemaker is a plus.
* Proficiency in labeling software systems (LabelView, Loftware, Prisym, enLabel, Robar, etc.) is a plus.
* Proficiency with thermal transfer label printers (Zebra, SATO, DataMax) is a plus.
* Graphic design and development preferred.
* Auditor certification (i.e., CQA, CBA, RAB) or equivalent experience is a plus.
* Documented continuing education in regulatory affairs or RAC certification is a plus.
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.
Internal Number: 5254BR
About Olympus Surgical Technology America
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran s...tatus, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled