Regulatory Affairs Administrator I Job at Olympus Corporation of the Americas
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
This position is responsible for initiating, administering and processing all complaint and Medical Device Report (MDR) files. Perform duties and responsibilities with instruction from more senior level Administrator staff and/or RA Supervisor.
Job Duties
- Handle the complaint receiving process.
Enter complaint information received from internal and external sources into complaint databases as appropriate.
- Prepare complaint files for processing by other department members in accordance with established work instructions.
- Maintain complaint and MDR files on site and manage the off-site archiving.
- Prepare routine RA/QA WIP (Work In Progress) and PMDR (Product Medical Device Report) regularly.
- Facilitate product RA investigations by transferring devices returned for evaluation to appropriate physical inventory areas upon receipt.
- Generate customer correspondence for complaint files. Reviews files for closure and completeness.
Perform other related duties as assigned.
Job Requirements
REQUIRED QUALIFICATIONS:
A high school degree or equivalent is required. Associate's degree preferred.
0 to 2 years’ experience in medical devices (preferred) or pharmaceuticals administration.
Computer literate with good working knowledge of all MS Office applications and Lotus Notes.
Good analytical, organizational, communication and interpersonal skills are required.
- Good attention to detail. Able to work in a fast pace environment.
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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
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 ||
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