BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Durham, North Carolina
Job Description SummaryThe associate will be responsible for the preparation of regulatory product submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
Prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports.
Assesses regulatory pathways for new product platforms and product modifications; develops/ implements regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies, as needed.
Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
Participates on cross-functional product development teams to ensure the business is positioned to meet strategic corporate goals.
Assists in the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market studies in support of US FDA and international regulatory submissions, as required.
Assists in the regulatory review of labels, labeling, advertising and promotional materials.
Interprets statutes, regulations, policies and guidance documents for business teams, product development/support teams, and to others in the business.
Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business.
Maintains proactive and positive working relationships with internal and external customers, both US and Ex-US, to ensure the business is positioned to meet strategic corporate goals.
Manages and monitors multiple and/or diverse projects simultaneously, including projects that involve several functional areas.
Bachelor's degree in scientific field or equivalent regulatory/scientific experience.
Minimum 3years of regulatory experience in the medical device and/or in vitro diagnostic device area(s), or advanced Regulatory Affairs degree.
Working knowledge of medical device and/or in vitro diagnostic deviceregulations, 510(k) and/or Premarket Approval (PMA) process.
Experience supporting product development and/or product support projects.
Demonstrated abilityto effectively communicate both verbally and in writing.
Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
Experience maintaining confidential information at appropriate levels within an organization.
Experience with in vitro diagnostic devices.
Experience with Class III medical device and/or in vitro diagnostic device submissions.
Experience working directly with US FDA, Notified Bodies and/or international Competent Authorities.
Experience preparing, filing and completing regulatorysubmissions [510(k), PMA, Technical Files and other regulatory documentation].
Primary Work LocationUSA NC - Durham (Tripath Oncology)
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