Job Description Summary

As Regulatory Affairs, Compliance Sr. Manager, you will be responsible for developing and implementing the global regulatory strategy for MMS Medical Device and non-Medical device products and software. Associates will be expected to work Monday through Thursday in either our San Diego or Irvine Laguna Canyon, CA locations, and work at home on Friday.

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. 

Primary Responsibilities:

• Develop and implement global regulatory strategy for MMS Medical Device and non-Medical device products and software

• Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)

• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World

• Ensure QMS requirements are followed and executed consistently from a regulatory affairs perspective

• Oversee efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content

• Support regulatory impact assessments for change controls and other RA/QA items from a review and approval level

• Assist in preparing, auditing, editing, and publishing registration documentation as needed

• Support business export control (BEC) listing of product for release globally per RA requirements

• Support the review and approval of product labeling, promotional, and advertising materials as needed

• May supervise a team of associates and managers

About You: To be successful in this role, we require:

• Minimum bachelor’s degree in RA, QA, engineering, or other science-related field

• Advanced degree (e.g. MS, Life Sciences) preferred

• Minimum of 10 years of strong Regulatory Affairs/Compliance experience in medical devices

• Minimum of 5 years of supervision (direct report) experience including performance evaluations and career development is preferred; coaching and mentoring experience is required.

• Software experience, including SaMD/SiMD experience

• Project Management experience

• Knowledge of global Regulatory Affairs requirements, regulations, and standards

• Strong prioritization, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects while partnering with cross-functional colleagues to identify regulatory innovation

• Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and a willingness to make changes when needed

• Ability to travel globally up to 20% of the time

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. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. ​

$158,300.00 - $261,100.00 USD Annual

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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