BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Tempe, Arizona
Category: Medical Device/ Regulatory Affairs
Job ID: 2018-11485
Career Level: experienced
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-JC1
Summary of Position with General Responsibilities:
The position of Regulatory Affairs Specialist is responsibe for the development and support of China FDA product registrations with International Business Center (IBC) contacts in China. The candidate will be expected to write submissions in conjunction with other departments, requiring a working knowledge of the products and relevant Chinese regulations and guidance documents.
Essential job Functions:
Prepares and supports China FDA first time, renewal, and change registration submissions as required and per applicable 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.
Provides international regulatory support on Engineering Change Orders, Design Change Notices, and other deviations.
Knowledgable of Bard Peripheral Vascular’s compliance to FDA, European and international regulations and standards.
Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
Special projects, as needed.
Knowledge of U.S., European, and international regulations and standards.
Minimum of 2 years of regulatory experience, preferably within the medical device industry.
Experience working with international businesses or cultures.
Additional Desirable Qualifications Skills and Knowledge:
Excellent communication (both verbal and written) skills.
Sufficient computer skills (Windows environment).
Good problem-solving and analytical skills.
Detail oriented with strong Excel knowledge. Ease with manipulation of data.
Mandarin language skills preferred.
Knowledge of Chinese regulations and standards preferred.
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