BD (Becton, Dickinson and Company) Regulatory Affairs Assistant in New Hope, Minnesota
Job ID: 2018-12409
Career Level: entry level
Location: New Hope,Minnesota,United States
Trailblazing Innovation for Patients
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients . Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
Summary of Position with General Responsibilities:
This position will be responsible for providing regulatory support to the international and internal regulatory team for submission filings and maintenance of regulatory database systems for compliance with required regulations.
Essential job Functions:
Provide regulatory documentation to international regulatory team for preparation of the local submission filings.
Plan, organize and maintain international filing status and communication status to product development project teams.
Drive documentation reviews required to support international filings.
Ensure international regulatory affairs files are updated and maintained as required.
Develop working relationships with international regulatory team and gain understanding of the international support document necessary for each associated countries.
GED or High School Diploma required, Bachelors Degree preferred
4 years’ experience working in office environment or equivalent.
Excellent written and oral communication skills
Strong organizational and interpersonal skills
Ability to effectively manage multiple projects with shifting priorities
Independent decision making and analytical thinking skills
Proficiency with Microsoft Office software
Ability to work independently with minimal supervision
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Employee must be able to wear personal protective equipment. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fastpaced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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