BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist in Franklin Lakes, New Jersey
Job Description SummaryThis position will be responsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions for medical devices. The incumbent will perform essential duties and responsibilities with some supervision .
Represent the Regulatory Affairs function at the global cross functional business or product platform level
Analyze and interpret current or proposed domestic and international regulations for impact to BD products and processes to help ensure continuous compliance.
Develop and execute global regulatory strategies by collaborating closely with cross-functional product development teams and regulatory associates around the world.
Assess the impact of device modifications and develop robust non-filing justifications for US/EU regulated products Coordinate and prepare premarket applications to the US FDA such as pre-submission meetings, 510(k)s...
Coordinate and prepare submissions to European Notified Bodies for timely approval of new products and product changes.
Provide support to regional regulatory associates for timely approval of BD products worldwide.
Review and approve product labeling for compliance to global regulatory requirements.
B.S. degree or higher in a technical discipline, preferably in engineering, bio-engineering, biology, or chemistry.
At least 3 years of experience with medical device regulations is required.
Understanding of regulatory frameworks and the ability to interpret and apply new or emerging regulations.
Strong organizational and written/verbal communication
Attention to detail
Demonstrated problem solving abilities
Self-motivated with the ability to effectively manage and prioritize multiple complex tasks
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