BD (Becton, Dickinson and Company) Regulatory Affairs Associate - Shonin in Tempe, Arizona
Job ID: 2018-12203
Career Level: entry level
Division: Bard Peripheral Vascular
Location: Tempe,Arizona,United States
Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.
Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world . #LI-SF1
Summary of Position with General Responsibilities:
The position of Regulatory Affairs Associate is responsible for the development and support of product registrations inJapanthrough collaboration with International Business Unit contacts. This is a 3 year project. The candidate will be expected to write submissions in conjunction with other departments, requiring a working knowledge of the products and relevant regulations and guidance documents inJapan.
Essential job Functions:
Prepares and supports product registrations inJapanin both newly introducing and sustaining products in the market as required and per applicable standard operational procedures (SOPs).
Provides general support for international regulatory team and projects, as needed.
Participates in product development and line extension teams, as required, to ensure that the product is in compliance with all international regulatory requirements. Develops documents and implements a regulatory submission plan around product development and line extension goals.
Assists in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
Provides international regulatory support on Engineering Change Orders, Design Change Notices, and other deviations.
Researches and responds to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
Performs on special projects as required.
Good written and oral communication skills in English language.
Basic computer skills (Windows environment).
Detail-oriented and critical thinking.
Ability to plan and schedule multiple priorities in a concurrent fashion.
Ability to review, collate and summarize scientific and technical data.
Good problem solving and analytical skills.
Intercultural communication skills desirable.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status