Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Overview

As Staff Specialist, Regulatory Affairs, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.  You will focus on Medication Management Solutions system products with hardware, software and/or interoperability with other devices or external networks. In this role, you will have primary RA responsibility for multiple FDA Class II products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.  You will be expected to work onsite Monday through Thursday in our San Diego, CA office and work remotely Friday on a weekly basis. 

Primary Responsibilities:

• Provide regulatory support for both new and currently marketed products.  Work to resolve potential regulatory issues and questions/deficiencies from regulatory agencies.

• Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.

• Lead the preparation of regulatory submission sections for new products and product changes, as required, to ensure timely approvals for market release

• Interact directly with FDA and/or notified body at reviewer level. Participate in negotiations and interactions during the review process.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

• Provide regulatory input to product lifecycle planning.

• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items.

• Provide feedback and support to product development teams for regulatory issues and questions.

• Ensure personal understanding of all quality policy/system items that are personally applicable.

• Follow all work/quality procedures to ensure quality system compliance and high-quality work

Education and experience:

• Minimum bachelor’s degree in engineering, Life Sciences, or a related field

• Minimum 3 years of practical experience regulatory affairs, with a focus on medical device systems

• Knowledge of international regulatory requirements (e.g., FDA QSR, ISO 13485, IEC 62304)

• Solid understanding of risk management processes (ISO 14971)

• Exceptional analytical and problem-solving skills

• Excellent written and verbal communication skills, including regulatory writing

• Strong attention to detail and organizational skills.

• Ability to work collaboratively in cross-functional teams.

• Proficiency with regulatory databases, document control systems, and project management tools

Preferred Qualifications:

• Certification in regulatory affairs (e.g., RAC)

• Experience working with regulatory submissions, interactions with regulatory agencies (e.g., FDA, BSI or other Notified Bodies), and working with cross-functional project teams        

• In depth experience with FDA requirements, guidance documents, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

• Experience with Software in Medical Device (SiMD), Software as a Medical Device (SaMD) and cybersecurity regulations

• Knowledge of electrical safety standards<