BD (Becton, Dickinson and Company) Regulatory Specialist/Sr. Specialist in Warwick, Rhode Island
Job ID: 2018-12362
Career Level: experienced
Location: Warwick,Rhode Island,United States
Summary of Position with General Responsibilities:
Summary/Purpose of Position
Provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device and combination product regulations in U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.
This position will play a key role in the new product evaluation and new product submission process as well as maintenance of existing product life cycles. Key responsibilities involve assurance that clinical evaluations and new product submissions are in compliance with applicable global medical device regulations, and regulatory support of change management activities. Failure to assure compliance to the regulations could have serious impact on company image and success in evaluation and marketing of products.
Essential job Functions:
Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k)
Rationales, international change notifications).
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD, International Dossier).
Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Support due diligence and business integration activities as assigned.
Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned.
B.S. or equivalent with emphasis on material science or mechanical engineering. Professional certifications preferred.
Knowledge and experience (minimum 3 years) with regulatory requirements for medicaldevices (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design dossiers).
Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
Working knowledge of statistics and electronic documentation and information systems
Ability and desire to travel as needed.
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