BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Franklin Lakes, New Jersey
Job Description SummaryThe roles and responsibilities of this position span over Diabetes Care’s key business platforms. This candidate is responsible for the preparation of regulatory submissions required to market new or modified medical devices in the U.S. while supporting Europe and other global markets as directed by business leaders. Responsibilities also include other related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
3-5 years Regulatory Affairs experience in medical device regulations
Demonstrated success in taking products through FDA, preferably CDRH.
International product registration experience preferred.
RACs certification preferred
KNOWLEDGE, SKILLS AND ABILITIES:
Proficient in using Microsoft Word, Excel and PowerPoint.
Strong communication and project management skills.
Able to handle multiple tasks and attention to detail.
Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC and working knowledge of 21 CFR 820 -Quality System Regulation, and working knowledge of standards and FDA guidance’s.
Knowledge of medical device cybersecurity, software and digital health requirements preferred.
Primary Work LocationUSA NJ - Franklin Lakes
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