Senior Specialist, Regulatory Affairs - Hybrid

BD (Becton, Dickinson and Company); San Diego (CA); On-site; USD 121,000 - 200,000; Full time

Job summary

An established industry player seeks a Sr. Specialist of Regulatory Affairs to support global medical device compliance. This role involves ensuring adherence to FDA and EU regulations while driving improvements in internal processes. Collaborate with cross-functional teams and contribute to innovative regulatory solutions. Join a company that values growth and creativity, fostering an inclusive environment where your contributions make a real difference in health care. If you're passionate about regulatory affairs and want to shape the future of medical technology, this is the opportunity for you.

Qualifications

• 5+ years of experience in Regulatory Affairs/Compliance in medical devices.
• Knowledge of global regulatory requirements and standards.

Responsibilities

• Support regulatory compliance with FDA and EU-MDR regulations.
• Drive continuous improvement in internal processes and customer satisfaction.

Skills

Regulatory Affairs

Compliance

Analytical Skills

Interpersonal Skills

Communication Skills

Project Management

Education

Bachelor’s degree in RA, QA, engineering, or related science field

Advanced degree (preferred)

RAPS RAC certification (preferred)

Job description

As Sr. Specialist of Regulatory Affairs, you will be responsible for supporting MMS Dispensing products, including Medical Devices, Non-Medical Devices, associated Software, and Accessories on a global basis from a Regulatory Affairs perspective. Your support will encompass new product development, sustaining activities, and end-of-life processes. Candidates must be able to work in our San Diego, CA office 4 days per week.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies. Advancing health is our purpose, achieved through innovative design, engineering, manufacturing, and marketing of billions of MedTech products annually. We aim to turn the impossible into possibilities.

We value the human element across our global teams, fostering an environment of learning, growth, and excellence. Join us and become a maker of possible.

Primary Responsibilities :

1. Support regulatory efforts to comply with regulations such as FDA Medical Device Regulations and EU-MDR.
2. Identify and escalate regulatory and compliance issues to senior management.
3. Drive continuous improvement in internal processes and customer satisfaction.
4. Monitor and interpret current and new regulatory requirements and international standards for the U.S. and Rest of World.
5. Ensure QMS requirements are followed and consistently executed from an RA perspective.
6. Assist in Technical File creation, remediation, and cross-functional collaboration.
7. Support regulatory impact assessments for change controls and other RA/QA items.
8. Prepare, audit, edit, and publish registration documentation as needed.
9. Support business export control listing of products for global release.
10. Review and approve product labeling, promotional, and advertising materials.

About You :

1. Bachelor’s degree in RA, QA, engineering, or related science field; advanced degree preferred.
2. RAPS RAC certification preferred.
3. Minimum of 5 years of Regulatory Affairs / Compliance experience in medical devices.
4. Knowledge of global regulatory requirements, standards, and regulations.
5. Strong prioritization, interpersonal, communication, and analytical skills, with the ability to manage multiple projects.
6. Excellent collaboration skills to partner with cross-functional teams for regulatory innovation.

Salary ranges are designed to be fair and competitive, reflecting experience, education, skills, and location. The offered salary will be based on these factors. Remote or field-based roles may have different arrangements.

Compensation & Work Environment

Salary Range: $121,100.00 - $199,800.00 USD annually

BD emphasizes on-site collaboration to foster creativity and innovation, requiring at least 4 days in-office per week, with flexibility for remote roles as specified.

Employment may require proof of full COVID-19 vaccination, subject to accommodations per law.

Why Join Us?

Join a team that values your contributions, encourages authenticity, and promotes growth. Help us reinvent health and make a difference in the world.

Additional Information

BD is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.