Manager, Regulatory Policy
Job Description Summary
The Manager of Regulatory Policy will play a critical role in interpreting and influencing the US regulatory environment to contribute to BD’s mission. The Manager will provide support to advance BD’s positions on US FDA regulatory policy and legislative issues. As a member of the Public Affairs team, the Manager will also support BD’s advocacy efforts in an evolving regulatory environment on behalf of patients and providers to ensure access to BD’s best-in-class products. This position will support the Director, Regulatory Policy in influencing strategies needed to achieve Corporate Regulatory goals identified as supporting KDGs for individual businesses and/or BDX overall.
- Monitors US FDA regulatory policy and legislative topics of interest to BD, supports internal monitoring and communication processes regarding US FDA regulatory environment, and supports coordination with business units’ regulatory affairs teams in developing and submitting BD comments on US FDA regulatory policy.
- Develops and maintains an awareness of the evolving internal and external regulatory needs and requirements; works collaboratively with both internal and external stakeholders to influence the regulatory policy environment.
- Represents BD in industry working groups as assigned to support regulatory policy and legislative proposals that align with BD strategic interests in pre- and post-market regulation of medical technology; summarizes and communicates policy meetings and events; plans and manages interactions and communications with trade associations on regulatory policy matters.
- Consults with internal experts and leadership to identify priority issues; prepares and delivers regulatory intelligence alerts, summaries, reports, and newsletters on regular schedule highlighting pertinent regulatory and legislative activities and potential impact on BDX products and businesses.
- Remains current on legislation, US FDA regulations, and guidance documents related to BD products and keeps an open line of communication to key stakeholders including interactions with US FDA.
- Assist with additional regulatory projects as assigned.
- Bachelor’s degree required in a technical discipline, with a minimum of 3 years of related professional experience; advanced degree desirable
- Strong working knowledge and experience with current FDA medical device regulatory requirements
- Ability to organize diverse projects in a timely manner
- Working knowledge of electronic documentation and information systems
- Strong background and history of managing projects with proven track record of successful outcomes
- Excellent interpersonal, oral and written communication skills with the ability to work effectively with members of cross-functional teams
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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Job posted: 2020-11-18