Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry.
TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients.
TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6 billion in sales, 30,000 employees worldwide and operations in more than 160 nations.
Terumo Medical Corporation is comprised of two strategic business divisions : Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career.
We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements.
Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets.
This position will prepare documents and / or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide.
Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.
e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation.
Job Details / Responsibilities
Stays abreast of Regulatory Agency updates including new policies and guidance’s.
Knowledge, Skills and Abilities (KSA)
These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.
Qualifications / Background Experiences
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law.
As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.