The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Postmarket Surveillance, Quality/Risk Management
2 Year Degree
Req ID: 788
Working Location: MASSACHUSETTS, SOUTHBOROUGH; PENNSYLVANIA, CENTER VALLEY
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.
The Field Action Engineer II provide engineering support for PMS system, specifically, interactions with the Food and Drug administration with regards to corrections and removals. The incumbent is instrumental in contributing to defining the direction and plans for recalls and ensuring 21 CFR 806 compliance. He/ she will lead, monitor, and manage recalls, corrections and removals to completion and closure.
* Function as primary contact and coordinator on all recalls.
* Coordinates and organizes Site Corrections and Removals (recalls).
* Expedites the coordination of activities for timely FDA reporting and interfaces with all internal stakeholders, including Service, Supply Chain, Marketing, and Product Managers.
* Acts as the Quality representative for communication and interfacing with the FDA regarding Field Safety Notice and Recall Notifications
* Assists and coaches’ employees on Correction and Removal regulations.
* Maintains Quality Recall Dashboard metrics for input into Management Reviews and Quality Progress Meetings.
* Coordinates, monitors, and analyzes trending of Recall data for Monthly Quality Data Review and Management Review Meeting (MRM) discussion.
* Ensures corrections, removals and recalls are managed effectively and efficiently.
* Support decision making for Health Hazzard Assessments, Vigilance Reporting, CAPA, and Recall based on analysis and trending of post-market data sources.
* Assists with onsite Notified Body and FDA inspections and maintenance of formal responses to findings.
* Perform all other related duties as assigned.
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) || Pennsylvania (US-PA) || Center Valley ||
* Requires a Bachelor's Degree in Engineering or an Associate’s Degree in Engineering Technology
* Minimum of 3 years’ experience in Medical Device Quality Compliance in the medical device industry.
* Recall experience to include submissions of 806 reports required.
* Experience interacting with regulatory bodies – FDA.
* Possess a high degree of self?reliance, initiative, creativity, and personal organization.
* Demonstrated excellent written and oral communications.
* Must have working knowledge of FDA medical device regulations desirable.
* Knowledge of Oracle, Agile and Microsoft Office.
Internal Number: 788
About Olympus Corporation of the Americas
OLYMPUS IS TRUE TO YOUR CAREER
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, life sciences, industrial solutions, cameras, and audio recorders.
We view our relationship with a commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our purpose 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.