BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist in Durham, North Carolina
Job Description Summary
Staff Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; executing regulatory product submissions, from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and post-market activities, as required; exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.
Manages planning and preparation of regulatory submissions (510(k), PMA, PMAS, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international regulatory agencies, including submissions for pre- and post-market requirements. Ensures regulatory submissions are prepared and processed in a proactive, expeditious and timely manner.
Represents the business in interactions with regulatory authorities. Plays a prominent role in complex negotiations regarding clinical and analytical study designs during the product development (pre-submission) phase, as well as the appropriateness of product claims, wording, and interpretation/presentation of performance during the verification/validation (pre-clearance/approval) phase.
Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies.
Identifies and communicates potential risks and risk mitigation strategies to stakeholders.
Partners with business leadership to develop, maintain, and execute domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
Participates on cross-functional product development teams representing the Regulatory Affairs function.
Assists in the planning and design of internal studies (including feasibility studies), clinical studies and post-market studies in support of US FDA and international regulatory submissions.
Accountable for establishing, maintaining, adjusting and communicating regulatory submission deadlines to ensure that all product-launch related functional area activities can be planned accordingly.
Manages and executes the regulatory review of labels, labeling, advertising and promotional materials.
Develops policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
Interprets statutes, regulations, policies and guidance documents for business teams and product development/support teams. Communicates impact to product development, manufacturing, and/or marketing teams.
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.
Provides training to cross-functional teams on a various regulatory issues and processes.
Acts as a mentor to other Regulatory Affairs associates, participating in development discussions and assisting other associates with developmental tasks and projects.
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.
Independently manages and monitors multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
B.S. degree or higher in scientific field or equivalent regulatory/scientific experience.
Advanced degree and/or RAC certification preferred.
Minimum 5-8 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
Working knowledge of medical device and/or in vitro diagnostic device regulations, 510(k) and/or Premarket Approval (PMA) process.
Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation).
Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues.
Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
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 US FDA Class III medical device and/or in vitro diagnostic device submissions (PMA, PMAS, Annual Reports).
Experience working directly with FDA, notified bodies and/or international health authorities.
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