Staff Regulatory Affairs Specialist

Becton Dickinson Medical Devices•San Diego, CA

8d•$129,600 - $207,400•Onsite

About The Position

This position prepares and executes regulatory submissions required to obtain and maintain market authorization for new and modified medical devices in the United States, Europe, and other international markets. It leads and supports regulatory affairs activities, including developing, implementing, and managing processes, procedures, and systems that ensure compliance with applicable global regulations throughout the product lifecycle. The role partners with cross-functional teams to ensure product development activities and design changes comply with regulatory requirements while supporting business objectives and commercialization strategies. The position ensures regulatory requirements are addressed across verification and validation, risk management and usability, reprocessing and biocompatibility, and software development. It independently analyzes and resolves complex regulatory issues, evaluates technical and clinical data, applies risk-based decision-making, and develops regulatory strategies that support product development, lifecycle management, and organizational goals. The role may provide leadership by assigning work and resolving complex problems. The position is based at BD’s San Diego, California location. BD states that most roles require at least four days per week in the office. Compensation is listed as $129,600 to $207,400 USD annually.

Requirements

Bachelor’s degree in Regulatory Science, Biomedical, Pharmaceutical, or a related scientific field, or equivalent.
At least 5 years of Regulatory Affairs experience in the medical device industry.
Medical device regulatory submission experience for the United States, Europe, and/or international markets.
Demonstrated success preparing and completing regulatory submissions, including negotiations, such as PMA, 510(k), and IDE submissions to the FDA and other regulatory agencies.
Experience supporting product development, design changes, and product lifecycle management.
Ability to evaluate technical and clinical data and independently resolve complex regulatory issues.
Knowledge of regulatory requirements across verification and validation, risk management, usability, reprocessing, biocompatibility, and software development.
Demonstrated ability to resolve problems and make appropriate regulatory decisions under pressure.
Strong cross-functional communication and risk-based regulatory strategy development skills.

Nice To Haves

Experience with FDA Class II and/or Class III medical devices is preferred.

Responsibilities

Coordinate, prepare, and follow up on FDA Premarket Notification 510(k) submissions in a timely manner.
Act as liaison with the FDA regarding product clearance.
Assess whether proposed device changes require a 510(k) application.
Prepare internal U.S. Non-Filing Justifications for changes that do not require a 510(k) submission.
Prepare technical files and dossiers for international registrations, obtaining appropriate input from R&D, Quality, Manufacturing, and other functions.
Review and approve labeling, promotional, and advertising materials for regulatory compliance.
Represent Regulatory Affairs on product lifecycle development teams by reviewing, approving, and completing requirements.
Coordinate and collect registration information from R&D, Manufacturing, QA, Medical, and other applicable departments.
Represent Regulatory Affairs on design teams and projects, providing regulatory guidance throughout product development and coordinating team inputs for submissions.
Support international registrations related to product changes and new product launches.
Write and update standard operating procedures, work instructions, and policies as needed.
Coordinate and respond to customer requests for product data or information, including surveys and questionnaires.
May assign work and resolve complex problems.