Job Description Summary

Job Description

Associate Director, Regulatory Affairs is responsible for the creating and executing regulatory strategies and objectives in alignment with business needs. This includes the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe and related regulatory affairs activities, such as 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.

1. Provides regulatory leadership to assigned product development program teams providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.

2. Works with business leadership to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans

3. Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies

4. Prepares, or directs the preparation of, global regulatory submissions

5. Identifies and communicates potential risks and mitigations associated with reg. strategies

6. Coordinates interactions/negotiations with U.S. regulatory agencies and Notified Bodies;

7. Participates in public policy and advocacy efforts relevant to assigned products and platforms

8. Participates in internal/external trade, professional, and standards development organizations

9. Reviews and approves labels, labeling, and promotional materials

10. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.

11. Monitors worldwide regulatory developments (standards, guidance documents) and communicates emerging opportunities/concerns impacting BU products.

12. Carry out the above tasks with no supervision.

Experience and Education:

B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry).  Advanced degree preferred. 

Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields

Knowledge, Skills, and Abilities:

• Experience with Software and digitally connected devices

• Demonstrated project management, negotiation, and communication (written and oral) skills. Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.

• Demonstrated global perspective, customer focus, cross-functional collaboration and Experience with Medical devices and in vitro diagnostics preferred.

• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.

• Experience in negotiating with FDA personnel in the device (CDRH) and biologics (CBER) areas.

• Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions (PMA, 510(k), IDE) to FDA and other regulatory agencies.

• RAPS Certification and/or ASQ certification in Auditing. 

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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