Job Description Summary

As Sr. Manager of Regulatory Affairs, you will be responsible for supporting Electromechanical (EMI) products consisting of Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, change control, sustaining, and end of life activities. Candidates must work onsite (In San Diego CA, Milpitas CA, Sparks MD, or Franklin Lakes, NJ) 4 days a week in the office.

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 EMI Medical Devices 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 RoW

• Insure QMS requirements are followed and executed consistently from RA perspective

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

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

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

• May supervise a staff 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 discipline

• Advanced degree (e.g. MS, Life Sciences) preferred RAPS RAC certification 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/improvements 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 prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects  

• Excellent interpersonal, communication and analytical skills and the ability to partner with cross-functional colleagues to identify regulatory innovation

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

• Ability to travel globally up to 5% 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. (~155,200.00 - 256,800.00 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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/o