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BD (Becton, Dickinson and Company) RA Staff Specialist (Eastern Time Zone Remote) in Baltimore, Maryland

Job Description Summary

The Staff Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BDIDS Molecular Diagnostics products with desired claims. Proficient project/people management skills, establishes/achieves schedules and milestones for functional projects, provides performance feedback. Represents BDIDS Molecular Diagnostics in pivotal interactions/negotiations with regulatory agencies and participates in external efforts to influence policy making bodies and standards development organizations.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most ambitious global health issues.

Duties and Responsibilities:

  • Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Will prepare or coordinate the preparation of Pre-IDE, PMA, De Novo Petition, and 510(k) submissions. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.

  • Prepares or provides input into Technical Documentation Packages for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.

  • Represents the business in interactions with regulatory authorities. Plays a prominent role in sophisticated negotiations regarding (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase.

  • Coordinates and manages meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings.

  • Communicates (oral/written) with senior BD leadership as well as functional teams. Assesses and independently responds to feedback. Prepares formal written reports/documents for distribution within work unit and regions.

  • Interprets statutes, regulations, policies and guidance’s for business teams and product development/support teams, presenting how these impact product development, manufacturing, and/or marketing.

  • 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 or presentations in multiple subject areas to cross-functional groups across BD on a variety of regulatory topics.

  • Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.

  • Independently manages and monitors multiple complex, novel, and/or diverse 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 and participates in long term planning within the unit. Includes signature authority for associated documents.

Education and Experience:

  • B.S. Degree or higher in a technical field preferred, to include engineering, bioengineering, microbiology, molecular biology, cell biology, or chemistry.

  • RAPS Certification preferred (RAC).

  • Typically requires a minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).

  • Demonstrated experience in interpreting subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.

  • Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. May be recognized internally as technical or subject matter expert in multiple areas.

  • Demonstrated success in supporting product development and product support projects, including sophisticated projects involving ambiguity and rapid change.

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

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

  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.

  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.

Knowledge of Specific Procedures/Practices :

  • FDA regulations and policies applying to medical devices and in vitro diagnostic devices including, but not limited to, requirements for 510(k)s, IDEs, PMAs, labeling and promotional materials, and Research Use Only devices. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

  • EU regulations including, but not limited to, Medical Device Regulation (MDR) (2017/745) and IVD Regulation (EU) 2017/746 (https://eur-lex.europa.eu/eli/reg/2017/746/2017-05-05) . Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.

  • Solid understanding of 21 CFR 820 - Quality System Regulation, ISO 9001:2000, EN ISO 13485, EN ISO 14971, Good Clinical Practice, and Good Laboratory Practice.

  • Working knowledge of standards applicable to business unit products.

Location: This position is remote, supporting Eastern Time Zone. Open to a candidate within another time zone, but the candidate must be willing to join meetings that fall within business hours for the East Coast.

For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

USA NJ - Franklin Lakes

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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