BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in New Hope, Minnesota
Category: Regulatory Affairs Specialist
Job ID: 2018-11499
Career Level: experienced
Division: New Hope, MN / Lutonix
Relocation: Relocation Not Available
Location: New Hope,Minnesota,United States
Summary of Position with General Responsibilities:
This individual in this position will be responsible for global adverse event reporting, world-wide regulatory submissions and ensuring compliance with all the required regulations for assigned projects.
Essential job Functions:
Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals.
Prepares U.S. FDA submissions (e.g., IDE, PMA) as required and per applicable SOPs.
Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.
Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards.
Ensures adequate documentation of Bard Lutonix compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.
Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Lutonix notified body.
Minimum of 2 years Regulatory Affairs medical industry or related industry experience (medical device, pharmaceutical and/or healthcare)
Experience with regulatory oversight and filing of reportable pre- and post-market adverse events and vigilance reports a plus
Bachelors of Science or technical degree preferred
Excellent written and oral communication and technical writing skills
Strong organizational and interpersonal skills
Ability to effectively manage multiple projects with shifting priorities
General knowledge of FDA and European medical device regulations, including IDE, PMA, & MDD
Able to apply independent decision making and analytical thinking skills
Proficiency with PC computer and Microsoft Office software
Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred
Ability to work independently with minimal supervision
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