Job Description Summary

Job Description

Position Summary:

This entry level position will be responsible for preparing US and international regulatory submissions, providing regulatory support to the development team, and ensuring compliance with required regulations for assigned projects. 

Responsibilities:

• Participate in product development/line extension teams as the need arises 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.
• Drive Labeling and Copy review for products for domestic and International markets.
• Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.
• Prepares U.S. FDA submissions (e.g., IDE, PMA, annual reports) 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.
• Ensure adequate documentation of compliance to FDA, European and International regulations and standards.  Ensure Regulatory Affairs files are updated and maintained as required.
• Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and BDPI Notified Body.

Qualifications:

• Bachelors of Science or technical degree or equivalent experience
• Regulatory Affairs medical industry or related proven industry experience (medical device, pharmaceutical and/or healthcare), 0-3 years.
• Excellent written and verbal communication and technical writing skills   
• Strong organizational and interpersonal skills
• Ability to optimally manage multiple projects with shifting priorities
• General knowledge of FDA and European medical device regulations, including IDE, PMA, MDD & MDR beneficial
• 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 direction

Physical Demands:

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 is occasionally required to bend, lift, reach or stoop. 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. 

Work Environment:

The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment. 

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, or any other protected status.

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