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BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist in Baltimore, Maryland

Job Description Summary

Job Description

Responsible for the preparation of moderately complex regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical 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.

Requirements:

  • Understands and interprets medical device and in vitro diagnostic device (IVD) regulatory requirements worldwide and remains current on regulatory issues/trends affecting business unit products. Communicates assessment of issues/trends to RA colleagues, product development/support teams and others in the business.

  • Interprets statutes, regulations, policies and guidances for product development teams and communicates impact on product development, manufacturing and/or marketing.

  • Develops regulatory strategies for moderately complex submissions to FDA and other regulatory agencies.

  • Provides risk assessments of regulatory strategies and regulatory options to product development/support teams.

  • Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements.

  • Prepares and/or compiles Technical Files for CE marking as well as provides information required by ex-U.S. regulatory associates to register or license products outside the U.S. and EU. Assists RA subject matter expert during Technical Audits by Notified Bodies.

  • Interacts and negotiates with U.S. regulatory agencies. Organizes and manages meetings with regulators with minimal supervision, including development of agendas and training/preparation of company personnel attending these meetings. Plays a key role in negotiating clinical and analytical study designs during pre-submission phase and acceptable claims, wording, performance data, etc. at the pre-clearance/approval phase. Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.

  • Communicates (oral/written) with functional teams, assesses and independently responds to feedback. Prepares formal written reports/documents for distribution within work unit and regions.

  • Independently manages and monitors multiple moderately complex projects simultaneously, including projects that involve several functional areas without direct supervision. Maintains a “focused urgency” as required by specific events.

  • Formulates short term planning for individual deliverables within the unit.

  • Participates in the development and review of product release documents, including review of clinical protocols to assure collection of appropriate data for regulatory submissions.

  • Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data. Based on these data and considering the regulatory requirements, recommends appropriate courses of action. Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.

Qualifications

  • Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science. RAPS certification preferred.

  • Minimum 3 years of directly related regulatory experience in the medical device/in vitro diagnostic, biologic and/or pharmaceutical industry.

  • Demonstrates experience in interpreting U.S. medical device, in vitro diagnostic regulatory requirements, research use only requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); strong understanding of ISO 13485, European Medical Device and IVD Directive requirements and European quality system standards. Must be able to interpret these regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

  • Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

  • Ability to interpret requirements for labeling and promotional materials and remain within product claims.

  • Ability to handle multiple tasks, organize and prioritize work to meet business needs; project management experience desirable.

  • Demonstrated success in supporting product development and product support projects.

  • Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files).

  • Ability to analyze regulatory issues and to formulate cogent approaches to resolving/addressing issues.

  • Demonstrates understanding of technical/scientific principles for multiple product lines or manufacturing processes.

  • Able to exercise independent judgment and discretion with policies and practices.

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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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

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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