Job Description Summary

As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management of submissions, development and review of procedures and systems design to support regulatory processes, and address global regulatory requirements and business objectives.

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. 

Key responsibilities:

• Define regulatory strategy for infusion products.

• Prepare regulatory submissions (e.g., to FDA, Notified Body) for infusion products and product changes

• Review, approve, and author documents required for regulatory submissions to product.   

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners.

• Proactively lead regulatory efforts required to align with new regulations and requirements, i.e., EU MDR, MDSAP.

• Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance.

• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

• Work cross-functionally across multiple departments to communicate change impact.

• Remain current on standards and regulations affecting BD products and communicate and incorporate required changes.

• Support regulatory compliance activities, such as audits, CAPAs etc., as needed.

• Identify ways to improve the efficiency of current work process and implement them.

• Performs other duties and assignments as required.

Minimum Qualifications:

• Minimum bachelor’s degree required (Master’s degree in life sciences field preferred.)

• Minimum 5 years of strong Regulatory Affairs experience in the medical device industry.

• Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies.

• Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.

• Sound understanding of design control processes, FDA, and global regulations and standards.

• Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.

• Excellent interpersonal, communication and analytical skills.

• Knowledge of software and medical device design regulations and standards.

Desired/Additional Skills & Knowledge:

• Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity in medical devices.

Certifications:

• RAC desired.

Any Additional Information:

• Ability to travel up to 10%

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/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

PDN

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

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.

Salary Range Information

$121,100.00 - $199,800.00