BD (Becton, Dickinson and Company) Regulatory Affairs Specialist (remote) in Baltimore, Maryland
Job Description Summary
The Regulatory Affairs Specialist 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.
Education and Experience:
Bachelor of Science degree in a technical discipline (e.g., natural science or engineering).
Minimum of 3 years of relevant experience at a medical device and/or in-vitro diagnostic (IVD) manufacturer or in a related industry.
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.
Familiarity with medical device and/or in vitro diagnostic device regulations, 510(k) and/or Premarket Approval (PMA) process.
Demonstrated ability to effectively communicate both verbally and in writing.
Experience analyzing complex issues and formulating cogent approaches to address them.
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.
Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
Ability to communicate and interact effectively with members of cross-functional teams.
Always thinks globally and acts locally with cultural sensitivity and organizational savvy.
Openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
Ability to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
Advanced degree (MS, Ph.D., etc.)
RAPS Regulatory Affairs Certification (RAC)
Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
Experience preparing, filing and completing regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation).
Working knowledge of domestic medical device (including in vitro diagnostic) regulations, 510(k) and/or Premarket Approval (PMA) process, and international regulations/directives including the Canada medical device regulations and EU IVDD/IVDR, Japan PMD Act, and requirements for other Asia-Pacific and Latin America countries is preferred.
Direct experience with US Class I, II and/or III medical devices/IVDs
Expertise and experience in US and Ex-US registrations and submissions
Direct experience with broad range of IVD device types
Experience working directly with FDA, notified bodies and/or international health authorities.
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.
Primary Work LocationUSA MD - Baltimore
Work ShiftUS BD 1st Shift 830am-5pm (United States of America)
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.