Regulatory Affairs Specialist

4 days ago

Sparks Glencoe MD, United States BD Full time
Job Summary

The Staff Regulatory Affairs Specialist is responsible 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, providing instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BDDS Molecular Diagnostics products with desired claims.

Key Responsibilities:

  • Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies.
  • Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams.
  • Represents the business in interactions with regulatory authorities.
  • Plays a prominent role in complex negotiations regarding clinical and analytical study designs during the pre-submission phase and acceptable claims, wording, performance data, and other information at the pre-clearance/approval phase.
  • Organizes and manages meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings.
  • Communicates with senior BD leadership as well as functional teams.
  • Prepares formal written reports/documents for distribution within work unit and regions.
  • Interprets statutes, regulations, policies, and guidance for business teams and product development/support teams, communicating 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 disciplines to cross-functional groups across BD on a variety of regulatory topics.
  • Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) and analyzes feasibility and participates in developing, executing, or monitoring implementation plans.
  • Independently manages and monitors multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
  • Inspires effective unit dynamics and imparts a sense of commitment to unit goals.

Requirements:

  • Degree or higher in a technical discipline preferred, to include engineering, bioengineering, microbiology, molecular biology, cell biology, or chemistry.
  • Minimum 5 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
  • Demonstrated in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
  • Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
  • Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility.

Salary ranges may vary for Field-based and Remote roles.

For certain 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, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

We welcome people with the imagination and drive to help us reinvent the future of health.

To learn more about BD, visit

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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