Job Description Summary
This position is responsible for the development and implementation of product registration dossiers in support of international applications. The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards. The candidate will be expected to interface and communicate effectively with international business colleagues and regulatory authorities. Knowledge of international regulatory affairs is preferred.
Ensures adequate documentation of BD PI’s compliance to worldwide regulations and standards.
Prepares and supports international submissions and international product releases in accordance with applicable SOPs.
Maintains regulatory affairs files.
Develops working relationships with key personnel at the business unit and representatives of international business centers as well as with ministries of health.
Participates in new product development teams, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements. Reviews, documents, and supports a worldwide regulatory strategy in support of product development goals.
Education and Experience:
This position requires a Bachelor’s Degree in Law, Engineering, or one of the Life Sciences, or similar education.
The incumbent must have a minimum of 2 years of experience in a regulatory affairs or related field. Experience in International Regulatory Affairs is preferred.
Knowledge of a second language is preferred.
Ability to plan and schedule multiple priorities in a concurrent fashion.
Ability to review, collate, and summarize scientific and technical data.
Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.
Excellent problem solving and analytical skills.
Excellent written and oral communication skills.
Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
Complete work with minimal supervision and have the ability to work independently.
Knowledge of U.S. and/or international medical device regulations.
Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
Primary Work Location
USA AZ - Tempe BPV Building 3
San Jose , United States